FDA filings, source evidence and research calls in one place

Request a briefing

The opportunity

Reading settings Each track carries an 18 Hz binaural beat. Wear headphones: each ear hears its own tone.
501 Entities · 520 Claims · 32 Drugs · 646 Sources · as at 2026-10-31 Quotes as of 2026-11-10 00:36 UTC
This issue asks

Where is the biggest opportunity?

#1 in the next 90 days: Lorundrostat (Mineralys, MLYS), decision 22 Dec, potential return +86%.

How the potential return is worked out

Potential return is the probability of approval times the upside to the major banks’ median price target, less the probability of refusal times the fall on a refusal. The probability is how often applications like this one cleared their first FDA review, counted across every original application that reached a first FDA action from 1 January 2024 to 31 July 2026, refused ones included: 74.3% to 79.4% for filings we called above average and 60.6% to 67.2% for those called below, against 71.7% for all applications. The FDA does not publish whether a refused application had priority review, so 13 refusals could not be placed and each call has a range. The ranking uses its lower end. The signed calls are still scored on the rates sealed with them, 83.5% and 64.5%, which count approved drugs only. The fall is to the company’s net cash per share, read by hand from its latest filing, where the company is the drug, and otherwise the largest refusal-day fall the room has measured. A bank’s target counts when it is in the share price’s currency and under a year old; small research firms are not counted.

Supporting documentation

● our signed call above average, ○ below. Group: the first-cycle approval rate of filings in the call’s group, 74.3% above, 60.6% below. Upside: to the major banks’ median target.
Fall on a refusal: cash to the company’s net cash; measured, the largest refusal-day fall the room has measured. Dotted figures: hover for the source.

Potential return = group × upside + (1 − group) × fall, ranked
1
MLYS○
22 Dec · 42d · 60.6% group · upside +182% 4 banks: 3 buy, 1 hold · fall −62% cash
2
COGT●
30 Nov · 20d · 74.3% group · upside +79% 3 banks: 3 buy · fall −35.1% measured
Second filing on this share price, not ranked: · 30 Dec · 50d · ○ 60.6% group · potential return +34%
3
PRAX●
27 Dec · 47d · 74.3% group · upside +59% 8 banks: 7 buy, 1 hold · fall −35.1% measured
Second filing on this share price, not ranked: · 29 Jan · 80d · ○ 60.6% group · potential return +22%
4
VNDA○
12 Dec · 32d · 60.6% group · upside +83% 1 bank: 1 hold · fall −43% cash
5
SVRA○
22 Nov · 12d · 60.6% group · upside +108% 2 banks: 2 buy · fall −91% cash
6
BBIO●
27 Nov · 17d · 74.3% group · upside +41% 13 banks: 12 buy, 1 hold · fall −35.1% measured
Second filing on this share price, not ranked: · 4 Feb · 86d · ● 74.3% group · potential return +22%

Not ranked: Deramiocel, excluded from the ranking: an advisory committee voted 9 to 3 that the evidence did not show substantial effectiveness in the filed indication, and the sponsor then narrowed the indication by amendment; Anito-cel, net cash not read.

A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing. An opinion of the ontology. It cannot be bought and is not for distribution.
Decisions ahead

FDA decisions ahead, and what the market prices

One block per company, because a company has one share price, nearest decision first; its later filings follow in date order. Each figure shows its source and the time it was read. Select a drug to open its one-page brief.

12FDA decisions due in the next 90 days, to 8 February 2027, 1 of them dated only to a quarter
12 daysuntil the next: Deramiocel and Molgramostim, 22 November 2026
±74%the largest move options price for the decision alone, on Deramiocel
7 of 20filings with a regulatory concern recorded
The next 90 days
DecJan 2027FebToday8 February 2027CAPR · DeramiocelMLYS · LorundrostatPRAX · UlixacaltamideBBIO · InfigratinibSVRA · MolgramostimBBIO · BBP-418COGT · BezuclastinibVNDA · QuimilzaACLX · Anito-celPRAX · RelutrigineCOGT · Bezuclastinib (NonAdvSM)NVO · CagriSema, Q4 2026
No concern recordedConcern recordedMaterial concernExcluded from the rankingMark size: the options move for the decision alone; smallest where it cannot be isolated. Select a name to open its one-page brief.Filled: called above averageHollow: called below averageDashed: no callA band: the target is given only as a quarterGold line: 10 November 2026, the date this page was built

Refusal days measured, net of the XBI biotech index: -9.7% · -35.1% · -5.7% · +3.4% (4 refusals). The briefs’ 50% fall on refusal is an assumption; it ranks nothing.

no concern recordedconcern recordedmaterial concernexcluded from the ranking● our signed call: above average○ below average◌ no callrows joined: one share price
CompanyFiling · FDA dateOptions move: the decision alone · the whole straddle to its expiryNet cash, % of the price · runway, quartersUpside to the banks’ median targetInsider trades, 90 days
Capricor
CAPR
○22 Nov · 12 days
Complete response letter
PDUFA extended, indication narrowed
±73.6% · ±114.6% to 27 Nov42% · 7.6quotednone
Savara
SVRA
○22 Nov · 12 days
Refuse to File, insufficient CMC
PDUFA extended 3 months, major amendment
–a · ±89.0% to 18 Dec9% · 3.1+108%none
BridgeBio
BBIO
●27 Nov · 17 days
–a · ±11.6% to 18 Dec-20% · 34.8+41%sold $5m on a plan
●4 Feb 2027 · 86 days
±5.8% · ±18.7% to 19 Feb 2027
Cogent Bio
COGT
●30 Nov · 20 days
–a · ±19.8% to 18 Dec10% · 9.8+79%sold $2m on a plan
○30 Dec · 50 days
–a · ±24.1% to 15 Jan 2027
○29 Jun 2027 · 231 days
–b · ±53.4% to 21 Jan 2028
Vanda Pharmaceuticals
VNDA
○12 Dec · 32 days
–c · ±36.7% to 18 Dec57% · 4.9+83%bought under $0.1m
Mineralys
MLYS
○22 Dec · 42 days
±21.7% · ±38.9% to 15 Jan 202738% · 14.5+182%sold $3m outside a 10b5-1 plan; sold $2m on a plan
Arcellx, acquired by Gilead
ACLX
○23 Dec · 43 days
–gnot readdelistedn/a
Praxis Precision Medicines
PRAX
●27 Dec · 47 days
PDUFA extended 3 months, major amendment
–a · ±31.5% to 15 Jan 202714% · 15.7+59%none
○29 Jan 2027 · 80 days
±14.6% · ±41.3% to 19 Feb 2027
Novo Nordisk
NVO
●Q4 2026
–hnot read-3%n/a
Later than 8 February 2027
Belite Bio
BLTE
●12 Feb 2027 · 94 days
±20.9% · ±36.9% to 19 Mar 202712%+31%sold $32m on a plan
Otsuka (Taiho), with Cullinan, its U.S. co-developer
CGEM
●27 Feb 2027 · 109 days
REZILIENT3 reported 3 deaths from septic shock
–a · ±53.0% to 19 Mar 202747% · 9.3+156%sold $0.8m on a plan
Apnimed
APMD
○28 Feb 2027 · 110 days
FDA questions on the NDA's adequacy and requests for more data
FDA inspection findings at the contract manufacturer (Form 483, September 2025); resolved, per Apnimed's 10-Q of 8 September 2026
–i49% · 20.6+159%none
BioMarin
BMRN
◌28 Feb 2027 · 110 days
–d · ±20.5% to 16 Apr 2027-32%+53%sold $1m outside a 10b5-1 plan
Intellia
NTLA
○10 Mar 2027 · 120 days
FDA request for preclinical fetal data
–e · ±43.8% to 16 Apr 202732% · 7.2+24%sold under $0.1m outside a 10b5-1 plan; sold $0.4m on a plan
Inhibrx Biosciences
INBX
○14 Apr 2027 · 155 days
Partial clinical hold after a fatal liver injury, in place by 6 Mar 2023, lifted April 2023
FDA inspection findings (Form 483), disclosed 13 Aug 2026
–e · ±50.9% to 21 May 2027-3% · 7.8quotedbought $6m; sold $0.3m outside a 10b5-1 plan
Pharvaris
PHVS
○23 Apr 2027 · 164 days
–f · ±43.0% to 17 Jun 2027read in EUR, not set against the US share price+80%sold $16m outside a 10b5-1 plan; sold $5m on a plan; Modig Berndt disposed of $10m, filed as code M

Net cash is an anchor under a refusal, not a floor. Insider trades: none means no open-market trade; a trade filed under another code is shown with its code. – marks a move options do not price for the decision alone. Not isolable. The first expiry after the decision: b is 206 days later; d is 47 days later; f is 55 days later. a The expiry after the decision is priced no richer than the one before. c No pair of expiries brackets the decision closely enough. e The last expiry before the decision is 54 days earlier. Not priced: g no US-listed share is quoted for it; h its decision is dated only to a quarter, so no options expiry can bracket it; i there are no listed options on APMD, per the Options Clearing Corporation.

This public page is a sample. It covers 20 pending FDA filings (Deramiocel excluded from the ranking), chosen to show what the research can do. A KXCO room built for a fund covers any number of stocks, with live quotes, alerts, export and a data feed. Request a briefing.
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Filing brief

Deramiocel (CAP-1002)

Capricor, CAPR, $9.85 a share. Cell therapy for Duchenne muscular dystrophy. Also known as CAP-1002: “Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells” (CAPRICOR THERAPEUTICS, INC., 8-K of 24 August 2026).

When
22 November 2026, in 12 days · standard review · date re-read from the sponsor's own document
Call
○ below average · 60.6%, the first-cycle approval rate of filings called below average · signed 5 October 2026
Standing
excluded from the ranking
Money
upside not quoted
no potential return: excluded from the ranking: an advisory committee voted 9 to 3 that the evidence did not show substantial effectiveness in the filed indication, and the sponsor then narrowed the indication by amendment
cash runway at the last quarter’s spending: 7.6 quarters
Options
±114.6% across the decision: the options straddle to the first expiry on or after it
Our finding

The FDA's advisory committee voted against deramiocel in July 2026, after an earlier complete response letter, and Capricor has since asked the FDA to review the data for a refined proposed indication, upper limb function.

What would change our view. An FDA statement on whether it will review the refined proposed indication would change our view.

Written 14 October 2026 and approved by the owner on 14 October 2026, from the record entries it cites.

Recorded concerns

  • 2025-07-09 Complete response letter download.open.fda.gov ↗
  • 2026-08-24 PDUFA extended, indication narrowed capricor.com ↗
  • 2026-07-29 Advisory committee voted 9 to 3 against biopharmadive.com ↗
  • 2026-07-20 FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation sec.gov ↗
  • 2025-11-10 Pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses sec.gov ↗

Also on the record:

Filed for the cardiomyopathy of Duchenne muscular dystrophy. After the July 2026 advisory committee, Capricor asked the FDA to review the data for a refined proposed indication, upper limb function, the primary endpoint of HOPE-3 (8-K of 24 August 2026). sec.gov ↗

Research note, built from the record on 10 November 2026
  1. The record holds four setbacks against this filing: first, complete response letter (9 July 2025); second, pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses; third, FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation; fourth, advisory committee voted 9 to 3 against (29 July 2026). The FDA's target date is 22 November 2026, under a standard review.From the FDA's and the sponsor's documents in the record: biopharmadive.com ↗ download.open.fda.gov ↗ sec.gov ↗ sec.gov ↗.
  2. Our call, signed on 5 October 2026, is below average: none of the three features holds. A call concerns how the FDA will decide, not the share price.From the signed ledger, batch 1, signed 5 October 2026.
  3. Options price a move of ±73.6% for the decision alone, ±114.6% across the whole straddle to 2026-11-27, and no major-bank target is recorded.From Cboe delayed quotes, the major banks' own price targets and stockanalysis.com prices, each figure with the time it was read.

Four setbacks on the record before the FDA's target date

2025-06-18: a registered trial reaches its primary completion date2025-07-09: Complete response letter2025-11-10: Pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses2026-07-20: FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation2026-07-29: Advisory committee voted 9 to 3 against2026-08-24: PDUFA extended, indication narrowedThe FDA's target datetoday18 June 2025target 22 November 2026

Red: a setback. Green: progress. Black: another event. Grey square: a registered trial completes. Diamond: the FDA's target date. Hover over a mark for its date and event.

Source: the record's regulatory events and registered trials, from the FDA's, the sponsor's and the trial registry's documents, as at 10 November 2026.

Options price ±114.6% to the first expiry on or after the decision, the largest of 17 filings priced

±114.6%0%±114.6%17 filings priced

Source: Cboe delayed quotes, the at-the-money straddle on the first expiry after the decision, 27 November 2026, quote time 2026-11-09 22:29:44.

No scenario is drawn

No scenario is drawn: the banks' median target is not split for this filing.

Source: KXCO's scenario. The major banks' median price target, read 2026-10-20, is split into an approval case and a refusal case by the approval rate this filing's call carries across every application, the rate the first screen uses. The fall on refusal is an assumption, not a sourced figure.

Short interest at Capricor is 34.2% of all shares, the highest of 14 companies measured

34.2%0%34.2%14 companies measured

Source: FINRA consolidated short interest, settlement 15 October 2026; all shares from market value over price, per stockanalysis.com 2026-11-10 00:36 UTC.

The other side

The record holds nothing in the filing's favour, as at 10 November 2026.

What to watch

  • 20 November 2026 The last options expiry before the decision.
  • 22 November 2026 The FDA's target date.
  • 27 November 2026 The first options expiry after the decision.

Update log

  • 15 October 2026 Two statements recorded from the sources.
  • 5 October 2026 Our call was signed in batch 1.
  • 23 September 2026 One statement recorded from the sources.
  • 22 September 2026 Two statements recorded from the sources.
  • 18 September 2026 Four statements recorded from the sources.

The record behind this note

Our signed call

below average signed 2026-10-05, batch 1.

  • a drug rather than a biologic: no (capricor.com ↗)
  • priority review: no (The original BLA was granted priority review (Capricor 10-Q, 14 Aug 2026). The current clock is a Class 2 resubmission extended three months for a major amendment, to which no review designation applies.)
  • a sponsor with an approval in the FDA register: no (api.fda.gov ↗)

Regulatory history

  • 2025-07-09 Complete response letter download.open.fda.gov ↗
  • 2025-11-10 Pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses FDA inspection findings sec.gov ↗
  • 2026-07-20 FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation FDA inspection findings sec.gov ↗
  • 2026-07-29 Advisory committee voted 9 to 3 against Advisory committee vote against biopharmadive.com ↗
  • 2026-08-24 PDUFA extended, indication narrowed Target date extended capricor.com ↗

What the FDA wrote

BL 125842, letter of 2025-07-09

The HOPE-2 study failed to demonstrate efficacy for its prespecified primary efficacy endpoint, which was change from baseline to Month 12 in the mid-level (elbow) dimension of the Performance of Upper Limb version 1.2 (PUL 1.2), a neuromuscular outcome assessment. the FDA's letter ↗

Announced by the sponsor 2025-07-11, 2 days after the letter.

Scenario

No scenario: the banks' median target is not split for this filing.

Registered trials

TrialRegistrationStatusEnrolmentPrimary completionResult as reported
HOPE-3NCT05126758 ↗active not recruiting1062025-06-18The primary endpoint of HOPE-3 which addresses the skeletal muscle results was unaffected with Deramiocel demonstrating a statistically significant slowing of upper limb disease progression as measured by the Performance of the Upper Limb 2.0 scale (“PUL 2.0”) compared to placebo, with a least squares mean difference of 4.55 percentage points in favor of Deramiocel p=0.029, corresponding to a difference of approximately 1.2 point absolute change in total PUL 2.0. source ↗

HOPE-3 what the trial measured, quoted at source

Primary endpoint as registered: Change in the upper limb function Time frame: At Month 12 clinicaltrials.gov ↗

Patients: The study randomized 106 participants across 20 leading U.S. clinical sites. sec.gov ↗

Design and control: HOPE-3 is a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial consisting of two cohorts evaluating the safety and efficacy of Deramiocel in participants with DMD. sec.gov ↗

The application, per the sponsor: BLA supported by positive pivotal HOPE-3 Phase 3 results, including achievement of the primary endpoint and all Type I error-controlled secondary endpoints sec.gov ↗

Insider trades, 90 days

no open-market trades

Sources

biopharmadive.com ↗ capricor.com ↗ cgtlive.com ↗ download.open.fda.gov ↗ sec.gov ↗ sec.gov ↗

A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Key findings

Key findings and research corrections

Eight findings, each linked to its claims and sources, every figure recalculated at each build. Select a name under Evidence to open it in the evidence graph.

critical: bears on a decision still pending and rests on an FDA document or the sponsor's own filinghigh: every other finding

Three of the four refusals on this board with a published FDA letter were followed by approval

Regulatory history
What happened

Ultragenyx filed UX111 for accelerated approval and received a complete response letter in July 2025. After resubmission, the FDA granted it standard full approval on 17 September 2026, two days before its target date. Full approval is a higher standard than the accelerated pathway that Ultragenyx first sought, and it was granted on a 23.5 point higher Bayley-III cognitive score over natural history, p<0.0001. UX111 is the first treatment for its indication.

What the data show

The case is not isolated. Of the four refusals on this board whose FDA letter is published, three were followed by approval. In the fourth, the letter states that the registrational trial failed its primary endpoint.

The limit

Four cases cannot establish a rule. They are consistent with a distinction between a refusal that the sponsor can resolve and one that reflects a failed trial, but they do not establish a rate of approval after a refusal, or how likely any other application is to be approved.

Why it matters

A complete response letter is therefore not, on its own, a reason to expect a final refusal. The record can draw this distinction because each regulatory event in it carries a type and a date.

Evidencedrugs.com ↗

Our reading of hereditary angioedema changed within a week because the sponsors' evidence changed

Research update
What happened

On 17 September the record treated hereditary angioedema as an indication with several drugs but little direct competition. Deucrictibant treated an attack on demand and lonvo-z was a one-time preventive treatment, so the two addressed different needs. Pharvaris then reported the CHAPTER-3 trial, which takes deucrictibant XR into prevention, and that reading no longer held. The indication now carries 4 drugs (Deucrictibant IR, Deucrictibant XR, Icatibant (Firazyr), Lonvo-z), and Pharvaris competes with Intellia through a second drug of its own.

Why it matters

The earlier entry was not an error. The evidence changed, and the record holds both readings with the date of each. Dating every claim is what makes a change of this kind visible.

The limit

The overlap is between development programmes. It does not show that either drug will be approved, or how the drugs would share a market if they were.

Evidenceir.pharvaris.com ↗

11 drugs on the board carry at least one adverse regulatory or safety event

Evidence review
The method

Each regulatory event in the record has a type, such as a complete response letter, a refusal to file or an advisory committee vote. Adverse history can therefore be listed with a single query rather than judged case by case.

What the data show

In total, 11 drugs carry at least one adverse regulatory or safety event: AD109 (Oxnimbi) (FDA questions on the NDA's adequacy and requests for more data, FDA inspection findings at the contract manufacturer (Form 483, September 2025); resolved, per Apnimed's 10-Q of 8 September 2026); Apitegromab (Isembyld) (Complete response letter); Deramiocel (Complete response letter, PDUFA extended, indication narrowed, Advisory committee voted 9 to 3 against, FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation, Pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses); Fayuvi (rebisufligene etisparvovec-hopf) (Complete response letter); INO-3107 (FDA questioned eligibility for accelerated approval); Lonvo-z (FDA request for preclinical fetal data); Molgramostim (Refuse to File, insufficient CMC, PDUFA extended 3 months, major amendment); Ozekibart (Partial clinical hold after a fatal liver injury, in place by 6 Mar 2023, lifted April 2023, FDA inspection findings (Form 483), disclosed 13 Aug 2026); Pixclara (floretyrosine F 18) (Complete response letter); Relutrigine (PDUFA extended 3 months, major amendment); Zipalertinib (REZILIENT3 reported 3 deaths from septic shock).

The correction

Building the scoring formula exposed a fault in this classification. One event type covered both “the FDA is not planning an advisory committee”, which is favourable because it removes the risk of a negative panel, and “the advisory committee voted 9 to 3 against”, which is unfavourable. Scoring the two alike would have misread both. The classification now separates them. It also distinguishes a safety signal from a trial from a request by the regulator, because a different party acts in each case.

The limit

A recorded event describes what happened on its date, not the position today. A concern from an earlier review may since have been resolved, and an FDA decision not to hold an advisory committee is not an adverse vote.

Evidencebiopharmadive.com ↗

2 of the 277 people in the record link an approved drug to a pending one

Programme history
The method

The query looks for a person who was previously involved with an approved drug that is the regulatory precedent for a drug now pending. It returns 4 rows from 2 people.

What the data show

Berndt Modig and Jochen Knolle both connect to icatibant, which is the precedent for both Pharvaris drugs. Knolle is named as an inventor of icatibant and ran research and development at Jerini. Modig was Jerini's chief financial officer through its 2005 listing and its 2008 sale to Shire.

The limit

The result has a defined scope. The record names 277 distinct people in 280 person records, because 3 people appear both in an SEC filing and in a company announcement. The other 275 people, each listed in the People view, are linked to a company but to no earlier approval that this search found. The finding covers only the people in this record. It is not a survey of every executive in the sector, and it does not show that no one else in biotechnology links an approved drug to a pending one in this way. Nor does a link show that the person caused either approval.

Evidencesec.gov ↗
Method and limitations

21 PDUFA dates were re-read from the sponsors' own documents and 0 were carried forward

Source validation
What the data show

Every claim in the record carries the web address it came from and the sentence it was read from: 520 of 520, without exception.

What happened

The PDUFA dates were the weakest part of the record, because they were stored as properties of each drug rather than as claims, and those properties carried no source. When we added sources to them, the most important date on each row turned out to be the least well evidenced value in the file. We re-read 21 of the dates against the sponsor's own release or filing. The other 0 are carried forward from 17 September, with the reason recorded. For each of them, we read the cited page in full and it does not state the date. We deleted no carried-forward date. Bezuclastinib (NonAdvSM) and Bezuclastinib (AdvSM), added after the review, were read from the sponsor's own document when they were added.

The method

The method can be repeated. Between 2026-09-23 and 2026-10-20, KXCO fetched each sponsor release or filing, extracted the sentence that states the date and stored that sentence against the drug. Where no such sentence could be obtained, the date kept its 17 September source and the reason was recorded. Marking each date in this way shows the reader which dates were checked and which were not.

Evidenceir.intelliatx.com ↗

An unsourced PDUFA date was removed rather than replaced with a sourced one

Date correction
What happened

Baxdrostat carried a PDUFA date of 18 May 2026 that nothing in the record supports. The AstraZeneca release it cited gives no date, and the FDA's approval history gives 15 May 2026 as the decision date. We removed the unsourced date rather than replacing it with the sourced decision date, because we had no evidence that 18 May was ever the goal date, and a substitute would have introduced a second unsupported fact.

What the check found next

The same check then found a more serious case. In 6 drugs, the PDUFA date was a copy of the approval date, so each appeared to have been decided exactly on time. Comparing a value with a copy of itself measures nothing. We cleared all 6, and one genuine measurement remains: Fayuvi was approved 2 days early.

Evidencedrugs.com ↗

The composite score's first backtest failed because the dataset was researched unevenly

Model correction
What happened

We published a composite execution score, calculated as trials plus twice precedent plus twice earlier programme relationships minus twice adverse events, together with a backtest that it failed. The test compared the mean score of the approved drugs with that of the pending drugs, and the approved drugs scored lower.

The correction

We first explained the result as the score's inability to credit a company for a refusal it had overcome. That explanation was wrong. When we traced the result on 23 September, the gap was 1.45 points, and the adverse events term accounted for 0.08 of it. The remainder came from the way we had built the record. Only 1 of the 8 approved drugs had a registrational trial in the record, against 9 of the 12 pending drugs. The record began as a screen of live filings, so we researched the pending drugs and entered the approved drugs only as outcomes.

Why it matters

A comparison between a researched cohort and an unresearched one measures the difference in research, not a difference between the drugs.

Evidencedrugs.com ↗

The composite score was withdrawn because trial counts dominated its ranking

Model correction
What happened

We searched both cohorts again under one rule: phase 3 trials that name the drug and whose sponsor matches, excluding access and extension programmes. The approved cohort went from 0.12 registrational trials per drug to 4.25, and the pending cohort from 0.83 to 3.50. The gap closed and its sign reversed, with the approved cohort at +3.38 against +3.08 for the pending cohort, so the score now met the backtest's criterion.

Why we withdrew it

The resulting board, however, was led by CagriSema with 22 registered phase 3 studies and Orforglipron with 18, because Novo Nordisk and Eli Lilly can afford to run that many trials. The trials term counts studies, so a ranking built on it measures the size of the sponsor. Meeting the criterion with that ranking did not show that the score could predict FDA decisions, so we withdrew it on 23 September 2026 rather than adjusting it.

What replaced it

No composite score replaces it. We still show its components for each drug, because each one is a counted fact. The board is ordered by regulatory standing, read from dated events, and then by implied upside. The signed calls in the research portfolio are a separate method: each places one filing above or below the average filing and was signed before the FDA's decision.

Correction, 30 September 2026

Three of the CagriSema studies, RENEW 1, 2 and 4, test cagrilintide alone, and we removed them from the record. CagriSema now has 19 studies, and the pending cohort has 3.25 trials per drug. The reasoning is unchanged.

Correction, 21 October 2026

The rule was fixed to count only studies that give the drug in an experimental arm and are registered for the disease the filing is for. It took 23 studies out of the record, 8 of them CagriSema's, and CagriSema now has 11. The reasoning is unchanged.

Evidencedrugs.com ↗
Research on a fund's own holdings. KXCO builds the same source-linked evidence around the filings and companies a fund holds, covering every filing, FDA letter, registrational trial and insider trade. Each claim shows its source and the date it was read, and the status of every filing is checked twice a day. Ask for a briefing.
Start with the FDA board for each filing's status and dates. Every link in this dataset is a claim, and every claim shows the web address it came from and the sentence read there. Where a value is not recorded, the page says so instead of filling the gap. No probability model is used: the composite score was withdrawn on 23 September 2026, as the last two findings explain, and the board is ordered by each filing's regulatory standing, read from dated events, and then by its implied upside. Since 21 October 2026 the first screen ranks the filings due in the next 90 days by potential return, from each call's first-cycle approval rate counted across every application, refused ones included, the major banks' price targets and each company's net cash.
Terms explained
FDA, SEC
The US Food and Drug Administration, and the US Securities and Exchange Commission.
NDA, BLA, sNDA
A new drug application, a biologics licence application, and a supplemental application for a drug already approved.
PDUFA target date
The date by which the FDA has said it aims to act on an application, set under the Prescription Drug User Fee Act. It is a target, not a decision, and the FDA can extend it.
Complete response letter (CRL)
The FDA's letter saying it cannot approve an application in its present form, and why. A sponsor can resubmit.
Advisory committee
A panel of outside experts the FDA may ask to review an application. Its vote is advice. The FDA makes the decision.
Regulatory standing
Our tier for a pending filing, counted from the dated regulatory events recorded against it. No concern recorded: the dataset holds nothing against the filing, which does not make it safe. Concern recorded: something is recorded against it, including a complete response letter the FDA did not base on the evidence failing. Material concern: the FDA wrote that the study missed its endpoint, or an advisory committee voted against it. Standing describes the evidence. It is not a probability of approval.
Implied upside
The gap between the major banks' median price target and the current share price, as a percentage of the share price.
Options-implied move
The cost of an at-the-money straddle, a call and a put at the same strike on the first expiry after the decision, as a percentage of the share price. It is the move in either direction that the options market prices across the decision.
Scenario reward to risk
The share price gain in an approval scenario divided by the fall assumed for a refusal. The approval scenario is solved from the major banks' median target, taking the probability of approval its call carries across every application, 74.3% for a filing called above average and 60.6% for one called below and a 50% fall on refusal, which is our assumption. The ratio holds only under those two inputs.
CMC, CIK
Chemistry, manufacturing and controls; and the number the SEC gives every filer.
New on 11 October 2026 and 14 October 2026
New on 11 October 2026. Five new views of the record: the decision calendar, a search of the evidence, paired decisions, the call scorecard and data coverage.
New on 14 October 2026. We have published the portfolio's calls: 20 FDA filings, each called above or below the average filing and signed before its decision. Anyone can check them against the signed ledger.

Joined the board on 14 October 2026 · call: ● above average, ○ below average

CallFiling, companyDecision due
○Quimilza (imsidolimab)Vanda Pharmaceuticals12 December 2026
○INO-3107Inovio30 October 2026
○OzekibartInhibrx Biosciences14 April 2027
○AD109 (Oxnimbi)Apnimed28 February 2027
●RelutriginePraxis Precision Medicines27 December 2026
○UlixacaltamidePraxis Precision Medicines29 January 2027
The offer to funds
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Bank price targets

Analyst targets and implied upside

The current share price, market capitalisation and the major banks' median 12-month price target for each of the 26 listed companies in the dataset. Implied upside is calculated from the price and that target. The target is the median of the major banks' own published targets, each sourced to its rating action; small research firms are not counted. It is not a forecast by KXCO, and nothing here is investment advice. Prices: stockanalysis.com, read 2026-11-10 00:36 UTC; the banks' targets read 2026-10-20.

26companies quoted
23carry a major-bank target
+39%median implied upside, across 23 companies
+182%widest, Mineralys
CompanyTickerPrice Market capBanks' median targetImplied upside Assets on this board
MineralysMLYS15.79$1.4bn44.5
+181.8%		Lorundrostat
ApnimedAPMD15.85$660m41.0
+158.7%		AD109 (Oxnimbi)
CullinanCGEM11.7$753m30.0
+156.4%		Zipalertinib (co-develops in the U.S.), Zipalertinib + chemotherapy (first line)
SavaraSVRA5.04$1.3bn10.5
+108.3%		Molgramostim
InovioINO1.51$255m3.0
+98.7%		INO-3107
Vanda PharmaceuticalsVNDA4.1$248m7.5
+82.9%		Quimilza (imsidolimab)
PharvarisPHVS34.53$2.4bn62.0
+79.6%		Deucrictibant IR, Deucrictibant XR
Cogent BioCOGT33.55$5.8bn60.0
+78.8%		Bezuclastinib, Bezuclastinib (AdvSM), Bezuclastinib (NonAdvSM)
Praxis Precision MedicinesPRAX333.09$9.3bn530.0
+59.1%		Relutrigine, Ulixacaltamide
BioMarinBMRN57.23$11.1bn87.5
+52.9%		Vosoritide (Voxzogo)
BridgeBioBBIO77.94$15.2bn110.0
+41.1%		BBP-418, Infigratinib
Daiichi SankyoTSE:4568¥2809.0¥5.1tn¥3900.0
+38.8%		Ifinatamab deruxtecan
Scholar RockSRRK51.55$6.3bn70.0
+35.8%		Apitegromab (Isembyld)
Takeda and Protagonist TherapeuticsPTGX136.19$8.9bn181.0
+32.9%		Rusfertide (Mimrylo)
Belite BioBLTE157.35$6.3bn206.0
+30.9%		Tinlarebant
Otsuka (Taiho)TSE:4578¥11950.0¥6.3tn¥15050.0
+25.9%		Zipalertinib
IntelliaNTLA12.1$1.7bn15.0
+24.0%		Lonvo-z
AstraZenecaAZN189.31$297.2bn230.0
+21.5%		Baxdrostat (Baxfendy)
UltragenyxRARE16.42$1.7bn19.5
+18.8%		Fayuvi (rebisufligene etisparvovec-hopf)
Merck & CoMRK148.72$366.6bn163.0
+9.6%		Ifinatamab deruxtecan
TakedaTAK21.1$67.7bn21.0
-0.5%		Oveporexton (Orzeyful)
Eli LillyLLY1412.05$1.3tn1400.0
-0.9%		Orforglipron (Foundayo)
Novo NordiskNVO41.4$185.1bn40.0
-3.4%		CagriSema
3 quoted companies carry no major-bank target. They are shown without one rather than given a number it does not have.
FDA board

FDA filings, dates and source status

Each row shows a filing's regulatory status and the evidence recorded on it. A target date and a decision the FDA has already made are labelled separately. Hover over, select or tab to a date badge to see when the date was checked, or why it was carried forward. Figures underlined with dots open their source the same way.

How each date was checked

A reverified badge means we fetched the sponsor's own release or filing again and took the date from the sentence that states it. A sourced badge means the date was read from the sentence that states it in the sponsor's own document when the filing was added, and has not needed a second read. A carried forward badge means the date comes from our screen of 17 September and could not be reverified, and the badge gives the reason. The board shows 20 reverified, 2 sourced and 0 carried-forward date badges. The target date of Ifinatamab deruxtecan was also re-read; the sponsor withdrew the application, so it carries no badge. These count dates, not claims: of the claims in the record, 1 claim was recorded on the as-of date and 519 were carried forward with their original dates.

DrugCompanyDecision date or targetStatus PriceBanks' median targetRecorded evidence Regulatory concerns and safety signals
Inside 30 days, as at 10 November 2026
Deramiocel (CAP-1002)
cell therapy
Capricortarget2026-11-22 reverifiedexcluded9.85
$573m		no major-bank target1 registered trial5 concerns or signalsComplete response letterPDUFA extended, indication narrowedAdvisory committee voted 9 to 3 againstFDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observationPre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses
Molgramostim (MOLBREEVI)
inhaled protein
Savaratarget2026-11-22 reverifiedpending5.04
$1.3bn		10.5
+108.3% implied		2 registered trials2 concerns or signalsRefuse to File, insufficient CMCPDUFA extended 3 months, major amendment
BBP-418 (ribitol)
small molecule
BridgeBiotarget2026-11-27 reverifiedpending77.94
$15.2bn		110.0
+41.1% implied		1 registered trialnone recorded
Bezuclastinib (CGT9486)
small molecule
Cogent Biotarget2026-11-30 reverifiedpending33.55
$5.8bn		60.0
+78.8% implied		1 registered trialnone recorded
31 to 90 days
Quimilza (imsidolimab, ANB019)
antibody
Vanda Pharmaceuticalstarget2026-12-12 reverifiedpending4.1
$248m		7.5
+82.9% implied		1 registered trialnone recorded
Lorundrostat
small molecule
Mineralystarget2026-12-22 reverifiedpending15.79
$1.4bn		44.5
+181.8% implied		2 registered trials1 precedentnone recorded
Anito-cel (CART-ddBCMA)
BCMA CAR-T
Arcellx, acquired by Gileadtarget2026-12-23 reverifiedpendingdelistedn/a2 registered trialsnone recorded
Relutrigine (PRAX-562)
small molecule
Praxis Precision Medicinestarget2026-12-27 reverifiedpending333.09
$9.3bn		530.0
+59.1% implied		1 registered trial1 concern or signalPDUFA extended 3 months, major amendment
Bezuclastinib (NonAdvSM, CGT9486)
small molecule
Cogent Biotarget2026-12-30 sourcedpending33.55
$5.8bn		60.0
+78.8% implied		1 registered trialnone recorded
Ulixacaltamide (PRAX-944)
small molecule
Praxis Precision Medicinestarget2027-01-29 reverifiedpending333.09
$9.3bn		530.0
+59.1% implied		1 registered trialnone recorded
Infigratinib
small molecule
BridgeBiotarget2027-02-04 reverifiedpending77.94
$15.2bn		110.0
+41.1% implied		1 registered trialnone recorded
A quarter, no day given
CagriSema
peptide combo
Novo Nordisktarget2026-Q4 reverified quarter, not a datepending41.4
$185.1bn		40.0
-3.4% implied		11 registered trialsnone recorded
Later than 90 days
Tinlarebant (LBS-008)
small molecule
Belite Biotarget2027-02-12 reverifiedpending157.35
$6.3bn		206.0
+30.9% implied		2 registered trialsnone recorded
Zipalertinib (CLN-081, TAS6417)
small molecule
Otsuka (Taiho), with Cullinan, its U.S. co-developertarget2027-02-27 reverifiedpending11.7
$753m
The board tracks Cullinan's shares: Cullinan co-develops zipalertinib in the U.S., per Taiho's release, while Otsuka, Taiho's parent, is a far larger company listed in Tokyo. (CGEM)
30.0
+156.4% implied		3 registered trials1 concern or signalREZILIENT3 reported 3 deaths from septic shock
AD109 (Oxnimbi)
oral small molecule combination
Apnimedtarget2027-02-28 reverifiedpending15.85
$660m		41.0
+158.7% implied		2 registered trials2 concerns or signalsFDA questions on the NDA's adequacy and requests for more dataFDA inspection findings at the contract manufacturer (Form 483, September 2025); resolved, per Apnimed's 10-Q of 8 September 2026
Vosoritide (Voxzogo)
peptide
BioMarintarget2027-02-28 reverifiedpending57.23
$11.1bn		87.5
+52.9% implied		1 registered trialnone recorded
Lonvo-z (NTLA-2002)
in vivo CRISPR
Intelliatarget2027-03-10 reverifiedpending12.1
$1.7bn		15.0
+24.0% implied		1 registered trial1 concern or signalFDA request for preclinical fetal data
Ozekibart (INBRX-109)
antibody
Inhibrx Biosciencestarget2027-04-14 reverifiedpending91.62
$1.4bn		no major-bank target1 registered trial2 concerns or signalsPartial clinical hold after a fatal liver injury, in place by 6 Mar 2023, lifted April 2023FDA inspection findings (Form 483), disclosed 13 Aug 2026
Deucrictibant IR (PHA121, PHVS416)
oral small molecule
Pharvaristarget2027-04-23 reverifiedpending34.53
$2.4bn		62.0
+79.6% implied		3 registered trials1 precedent2 earlier programme linksnone recorded
Bezuclastinib (AdvSM, CGT9486)
small molecule
Cogent Biotarget2027-06-29 sourcedpending33.55
$5.8bn		60.0
+78.8% implied		1 registered trialnone recorded
Decided, withdrawn and not filed
Ifinatamab deruxtecan
ADC
Daiichi Sankyo2026-09-25 withdrawn
target was 2026-10-10, no decision will be made
withdrawn2809.0
¥5.1tn		3900.0
+38.8% implied		not rankednone recorded
INO-3107 (VOCERYQ)
DNA medicine
Inovio2026-10-30 decided
target 2026-10-30 reverified
approved1.51
$255m		3.0
+98.7% implied		1 registered trial1 concern or signalFDA questioned eligibility for accelerated approval
Fayuvi (rebisufligene etisparvovec-hopf)
AAV9 gene therapy
Ultragenyx2026-09-17 decided
target 2026-09-19 reverified
2 days early		approved16.42
$1.7bn		19.5
+18.8% implied		1 registered trial1 concern or signalComplete response letter
Apitegromab (Isembyld)
antibody
Scholar Rock2026-09-11 decidedapproved51.55
$6.3bn		70.0
+35.8% implied		1 registered trial1 concern or signalComplete response letter
Pixclara (floretyrosine F 18)
PET imaging agent
Telix Pharmaceuticals2026-09-11 decidedapproved9.92
$3.3bn		the banks' targets are in AUD, not the share price's currency0 registered trials1 concern or signalComplete response letter
Rusfertide (Mimrylo)
peptide
Takeda and Protagonist Therapeutics2026-08-28 decidedapproved136.19
$8.9bn		181.0
+32.9% implied		1 registered trialnone recorded
Oveporexton (Orzeyful)
small molecule
Takeda2026-08-05 decidedapproved21.1
$67.7bn		21.0
-0.5% implied		3 registered trialsnone recorded
Baxdrostat (Baxfendy)
small molecule
AstraZeneca2026-05-15 decidedapproved189.31
$297.2bn		230.0
+21.5% implied		6 registered trialsnone recorded
Orforglipron (Foundayo)
oral small molecule
Eli Lilly2026-04-01 decidedapproved1412.05
$1.3tn		1400.0
-0.9% implied		14 registered trialsnone recorded
Icatibant (Firazyr)
peptide
Jerini, acquired by Shire2011-08-25 decidedapprovednot listedn/a6 registered trialsnone recorded
Deucrictibant XR
oral small molecule
Pharvarisno target in this recordnot filed34.53
$2.4bn		62.0
+79.6% implied		not rankednone recorded
Zipalertinib + chemotherapy (first line)
small molecule
Cullinanno target in this recordnot filed11.7
$753m		30.0
+156.4% implied		not rankednone recorded
FDA letters

The FDA's letter and the sponsor's disclosure, side by side

Until 2025, the only public account of a complete response letter came from the company that received it. The FDA now publishes the letters. Where a filing on this board received one, this view sets the FDA's stated grounds, quoted from the letter and linked to the PDF on the FDA's website, beside the sponsor's dated disclosure. 4 of the complete response letters on this board are published, and 3 of those 4 applications were later approved. Four cases do not establish an approval rate.

4letters on this board, read at source
3 of 4approved after being refused
458letters in the FDA library
2026-08-13library last updated
Why the FDA's letter is the primary source. Each of these refusals was first recorded from a sponsor press release, or from trade press repeating one, which is the company's own account of its rejection. These four claims now cite the FDA's letter, and the sponsor's account is kept beside it so that a reader can compare the two. Reading the letters also found two that were missing from the dataset: Apitegromab and Pixclara were on this board as approved with nothing recorded against them, and both had received a complete response letter first.
The library, and what its shape does not mean. The FDA has published 458 letters. 309 of them belong to applications that were later approved and 149 are still unapproved. This is the split of the letters the FDA has chosen to publish, not a recovery rate for rejected applications. The agency says it also publishes batches from its archives associated with withdrawn and approved applications, so approvals are over-represented by construction. It is a fact about the library and it is cited as one. open.fda.gov ↗

The FDA's own page dates the contents of the database to 2025. It holds 32 from 2026, the most recent read here dated 10 April 2026.
approved 2026-09-11, 17 months after the letter

Pixclara (floretyrosine F 18)

Telix Pharmaceuticals
Letter dated 2025-04-25NDA 218592TLXRaised: chemistry, manufacturing and controls, clinical / statistical
What the FDA wroteThe clinical data submitted in this application did not provide substantial evidence of effectiveness for floretyrosine F 18.the letter, PDF ↗
What the market was toldOn April 28, 2025 (Melbourne, Australia), Telix Pharmaceuticals Limited (the "Company") filed an announcement with the Australian Securities Exchange ("ASX") titled “Telix Provides Regulatory Update on TLX101-CDx,” a copy of which is attached to this Form 6-K as Exhibit 99.1.sec.gov ↗
3 days passed between the date on the letter and the date the market was told. The letter is dated 2025-04-25. The announcement this record holds is dated 2025-04-28.
approved 2026-09-17, 14 months after the letter

Fayuvi (rebisufligene etisparvovec-hopf)

Ultragenyx
Letter dated 2025-07-07BL 125845RARERaised: chemistry, manufacturing and controls, facility inspection
What the FDA wrotePursuant to 21 CFR 601.20(a) and (d), at this time, CBER cannot determine that the product and establishment listed in the BLA comply with the standards established in the BLA and the requirements prescribed in FDA regulations, including Current Good Manufacturing Practice requirements.the letter, PDF ↗
What the market was toldJul 11, 2025 Ultragenyx Receives Complete Response Letter from FDA for UX111drugs.com ↗
Also in the same letterWe are currently evaluating the clinical data to determine if it adequately supports the proposed indication.
4 days passed between the date on the letter and the date the market was told. The letter is dated 2025-07-07. The announcement this record holds is dated 2025-07-11.
still not approved. Excluded from the ranked board.

Deramiocel

Capricor
Letter dated 2025-07-09BL 125842CAPRRaised: chemistry, manufacturing and controls, clinical / statistical
What the FDA wroteThe HOPE-2 study failed to demonstrate efficacy for its prespecified primary efficacy endpoint, which was change from baseline to Month 12 in the mid-level (elbow) dimension of the Performance of Upper Limb version 1.2 (PUL 1.2), a neuromuscular outcome assessment.the letter, PDF ↗
What the market was toldOn July 11, 2025, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) issued a press release announcing that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the Company’s lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).sec.gov ↗
Corrected on 2026-09-23

This dataset previously dated this letter 2025-07-01. The old value appeared in no quote in this record. It was a month taken from an article about the review extension and narrowed to a day it never stated. The FDA's letter carries the date on its face.

2 days passed between the date on the letter and the date the market was told. The letter is dated 2025-07-09. The announcement this record holds is dated 2025-07-11.
approved 2026-09-11, 12 months after the letter

Apitegromab (Isembyld)

Scholar Rock
Letter dated 2025-09-22BLA 761463SRRKRaised: chemistry, manufacturing and controls, facility inspection
What the FDA wroteThe deficiencies identified during the inspection may not be specific to your application.the letter, PDF ↗
What the market was toldOn September 23, 2025, the Company announced that the FDA has issued a CRL regarding the BLA for apitegromab for the treatment of SMA.sec.gov ↗
1 day passed between the date on the letter and the date the market was told. The letter is dated 2025-09-22. The announcement this record holds is dated 2025-09-23.
Clinical trials

Registered trials and their registry entries

Each trial behind a drug on this board is matched to its entry on ClinicalTrials.gov, the public registry, so a reader can open the study record directly. 77 of the 77 trial records are matched. Where a trial is not matched, or where the registry's figure differs from the one recorded here, the table says so.

77 of 77tied to a registration
73enrolments now read from the registry
2where our figure and theirs disagree
2026-09-23registry read on
How a trial was tied to a registration, and why the rule is strict. A trial is tied to a registration only where the registry's own record agrees with this one on the trial's name AND at least one further independent field, or where an exact enrolment this record already held matches alongside the sponsor and the drug. Sponsor plus drug alone was tried and rejected: it matched an expanded access programme and a long-term follow-up study, because every sponsor runs several studies of the same molecule.
Both cohorts were searched again, by one rule, on 21 October 2026. Run because the record held a registrational trial for 1 of 8 approved drugs and 9 of 12 pending ones. A comparison between a researched cohort and an unresearched one measures which cohort was researched.

A study counts as registrational for a filing when the registry says phase 3, or phase 2 and 3, the study gives the drug in an experimental arm, it is registered for the disease the filing is for, and its sponsor is the company this record holds as owning the drug, its named partner or a subsidiary that company lists. A combination counts only where the study gives it whole. A phase 2 study counts when the sponsor's own SEC filing describes it as registrational, in one of four set phrases, and that sentence is quoted with it. Expanded access programmes, long-term follow-ups, extensions, continuations and open-label extensions are excluded by name, because the first pass matched exactly those.

The rule found no registrational trial for 3 drugs, and they are named rather than left out:
  • Pixclara (floretyrosine F 18) · approved
  • INO-3107 · pending · the record holds the trial its application rests on, tied by the sponsor's own filing
  • Relutrigine · pending · the record holds the trial its application rests on, tied by the sponsor's own filing
Nine of these enrolments were held as zero, meaning unrecorded. They now carry the number the registry states. Two of the twelve differ from the figure already published here, and in both cases both figures are shown and neither is overwritten. A press release usually counts the population an endpoint was measured in, while a registry counts everyone enrolled, so the two can differ without either being wrong. No reconciliation is imposed without evidence for it.

Matched on: N the name · D the drug named in its title · R the drug named in the registration · S the sponsor · E the enrolment.

TrialCompanyRegistration StatusEnrolmentPrimary completion
LunAIRo
AD109 (Oxnimbi)
ApnimedNCT05811247 ↗
N R S
completed6602025-05-07
SynAIRgy
AD109 (Oxnimbi)
ApnimedNCT05813275 ↗
N R S
completed6462025-03-10
iMMagine-1
Anito-cel
Arcellx, acquired by GileadNCT05396885 ↗
N D S
active not recruiting1362026-12
iMMagine-3
Anito-cel
Arcellx, acquired by GileadNCT06413498 ↗
N D S
active not recruiting4522028-07
Bax24
Baxdrostat (Baxfendy)
AstraZenecaNCT06168409 ↗
N D S
completed2182025-08-17
BaxAsia
Baxdrostat (Baxfendy)
AstraZenecaNCT06344104 ↗
N D S
completed3262025-11-24
BaxDuo-Pacific
Baxdrostat (Baxfendy)
AstraZenecaNCT06742723 ↗
N D S
recruiting50002029-12-18
BaxHTN
Baxdrostat (Baxfendy)
AstraZenecaNCT06034743 ↗
N D S
completed7962025-05-21
BaxNoD
Baxdrostat (Baxfendy)
AstraZenecaNCT07686120 ↗
N D S
not yet recruiting2862028-02-09
NCT06268873
Baxdrostat (Baxfendy)
AstraZenecaNCT06268873 ↗
N D S
active not recruiting25542028-02-24
DRAGON
Tinlarebant
Belite BioNCT05244304 ↗
N D S
completed1042025-08-04
DRAGON II
Tinlarebant
Belite BioNCT06388083 ↗
N D S
active not recruiting602028-02
NCT03197766
Vosoritide (Voxzogo)
BioMarinNCT03197766 ↗
N D S
completed1212019-10-30
FORTIFY
BBP-418
BridgeBioNCT05775848 ↗
N D
active not recruiting1122027-09
PROPEL 3
Infigratinib
BridgeBioNCT06164951 ↗
N D S
completed1142025-12-18
HOPE-3
Deramiocel
CapricorNCT05126758 ↗
N D S
active not recruiting1062025-06-18
APEX
Bezuclastinib (AdvSM)
Cogent BioNCT04996875 ↗
N D S
recruiting1402025-09-19
PEAK
Bezuclastinib
Cogent BioNCT05208047 ↗
N D S
recruiting4822025-09-30
SUMMIT
Bezuclastinib (NonAdvSM)
Cogent BioNCT05186753 ↗
N D S
active not recruiting2372025-05-22
IDeate-Lung01
Ifinatamab deruxtecan
Daiichi SankyoNCT05280470 ↗
N D S
active not recruiting1872025-03-03
IDeate-Lung02
Ifinatamab deruxtecan
Daiichi SankyoNCT06203210 ↗
N D S
recruiting5402028-01-30
NCT06644781
Ifinatamab deruxtecan
Daiichi SankyoNCT06644781 ↗
N D S
recruiting5102028-06-01
NCT06925737
Ifinatamab deruxtecan
Daiichi SankyoNCT06925737 ↗
N D S
recruiting14402028-06-26
ACHIEVE-4
Orforglipron (Foundayo)
Eli LillyNCT05803421 ↗
N D S
completed27492026-03-16
ADVANCE
Orforglipron (Foundayo)
Eli LillyNCT06672549 ↗
N D S
recruiting1252027-02
ATTAIN-1
Orforglipron (Foundayo)
Eli LillyNCT05869903 ↗
N D S
active not recruiting31272025-07-25
ATTAIN-2
Orforglipron (Foundayo)
Eli LillyNCT05872620 ↗
N D S
completed16132025-08-08
ATTAIN-CN
Orforglipron (Foundayo)
Eli LillyNCT07790861 ↗
N D S
not yet recruiting1922028-03
ATTAIN-J
Orforglipron (Foundayo)
Eli LillyNCT05931380 ↗
N D S
completed2382025-06-19
ATTAIN-NOW
Orforglipron (Foundayo)
Eli LillyNCT07794579 ↗
N D S
recruiting20012029-08
ATTAIN-OSA
Orforglipron (Foundayo)
Eli LillyNCT06649045 ↗
N D S
completed7122026-07-21
NCT06584916
Orforglipron (Foundayo)
Eli LillyNCT06584916 ↗
N D S
completed3762025-11-21
NCT06672939
Orforglipron (Foundayo)
Eli LillyNCT06672939 ↗
N D S
recruiting1502027-12
NCT06948435
Orforglipron (Foundayo)
Eli LillyNCT06948435 ↗
N D S
active not recruiting4872027-09
NCT06972459
Orforglipron (Foundayo)
Eli LillyNCT06972459 ↗
N D S
active not recruiting8002027-08
NCT06972472
Orforglipron (Foundayo)
Eli LillyNCT06972472 ↗
N D S
active not recruiting6002027-08
NCT06993792
Orforglipron (Foundayo)
Eli LillyNCT06993792 ↗
N D S
active not recruiting14002027-08
ChonDRAgon
Ozekibart
Inhibrx BiosciencesNCT04950075 ↗
N R S
active not recruiting2062025-09-30
INO-3107 phase 1/2 study in RRP
INO-3107
InovioNCT04398433 ↗
R S E
completed322022-12-15
HAELO
Lonvo-z
IntelliaNCT06634420 ↗
N D S
active not recruiting802026-02-10
EASSI
Icatibant (Firazyr)
Jerini, acquired by ShireNCT00997204 ↗
N D S
completed1512011-06-22
FAST2
Icatibant (Firazyr)
Jerini, acquired by ShireNCT00500656 ↗
N D S
completed852006-07-25
NCT00097695
Icatibant (Firazyr)
Jerini, acquired by ShireNCT00097695 ↗
N D S
completed842006-07-17
NCT00912093
Icatibant (Firazyr)
Jerini, acquired by ShireNCT00912093 ↗
N D S
completed982010-10-01
NCT01386658
Icatibant (Firazyr)
Jerini, acquired by ShireNCT01386658 ↗
N D S
completed322018-03-12
NCT03888755
Icatibant (Firazyr)
Jerini, acquired by ShireNCT03888755 ↗
N D S
completed82016-02-12
Advance-HTN
Lorundrostat
MineralysNCT05769608 ↗
D S E
completed2852025-01-15
Launch-HTN
Lorundrostat
MineralysNCT06153693 ↗
D S E
completed10832024-12-10
NCT05813925
CagriSema
Novo NordiskNCT05813925 ↗
N D S
completed3312025-01-17
NCT06131437
CagriSema
Novo NordiskNCT06131437 ↗
N D S
completed8092025-12-08
NCT06388187
CagriSema
Novo NordiskNCT06388187 ↗
N D S
completed3002026-04-22
NCT06780449
CagriSema
Novo NordiskNCT06780449 ↗
N D S
active not recruiting4002028-08-28
NCT07011667
CagriSema
Novo NordiskNCT07011667 ↗
N D S
active not recruiting6092027-03-01
NCT07253285
CagriSema
Novo NordiskNCT07253285 ↗
N D S
recruiting4602030-03-20
NCT07357766
CagriSema
Novo NordiskNCT07357766 ↗
N D S
withdrawnnot recorded2027-11-29
NCT07564414
CagriSema
Novo NordiskNCT07564414 ↗
N D S
recruiting25002028-02-23
REDEFINE 1
CagriSema
Novo NordiskNCT05567796 ↗
N D S
active not recruiting34002024-10-30
REDEFINE 2
CagriSema
Novo NordiskNCT05394519 ↗
N D S
completed12002025-01-28
REDEFINE 6
CagriSema
Novo NordiskNCT05996848 ↗
N D S
completed3002025-01-06
REZILIENT1
Zipalertinib
Otsuka (Taiho)NCT04036682 ↗
N D S
active not recruiting176 here, 284 on the registry2025-10-13
REZILIENT3
Zipalertinib
Otsuka (Taiho)NCT05973773 ↗
N D
active not recruiting2852027-05-27
REZILIENT4
Zipalertinib
Otsuka (Taiho)NCT07128199 ↗
N D S
recruiting3602029-10-01
CHAPTER-3
Deucrictibant XR
PharvarisNCT06669754 ↗
N D S
active not recruiting85 here, 81 on the registry2026-08
CHAPTER-4
Deucrictibant IR
PharvarisNCT06679881 ↗
N D S
enrolling by invitation1702028-12
CREAATE
Deucrictibant IR
PharvarisNCT07266805 ↗
N D S
recruiting482027-06
RAPIDe-3
Deucrictibant IR
PharvarisNCT06343779 ↗
N D S
completed1342025-10-17
EMBOLD
Relutrigine
Praxis Precision MedicinesNCT05818553 ↗
N R S
active not recruiting772025-11-12
Essential3
Ulixacaltamide
Praxis Precision MedicinesNCT06087276 ↗
N R S
recruiting10002025-10-10
IMPALA-2
Molgramostim
SavaraNCT04544293 ↗
N D S
active not recruiting1642023-11-30
NCT06431776
Molgramostim
SavaraNCT06431776 ↗
N D S
recruiting52027-06
SAPPHIRE
Apitegromab (Isembyld)
Scholar RockNCT05156320 ↗
N D S
completed1882024-12-18
NCT06470828
Oveporexton (Orzeyful)
TakedaNCT06470828 ↗
N D S
completed1682025-06-03
NCT06505031
Oveporexton (Orzeyful)
TakedaNCT06505031 ↗
N D S
completed1052025-06-04
NCT07363720
Oveporexton (Orzeyful)
TakedaNCT07363720 ↗
N D S
active not recruiting982026-10-02
VERIFY
Rusfertide (Mimrylo)
Takeda and Protagonist TherapeuticsNCT05210790 ↗
N D S
active not recruiting2932025-02-21
Transpher A
Fayuvi (rebisufligene etisparvovec-hopf)
UltragenyxNCT02716246 ↗
N R S
recruiting362029-03
GEMINI-1
Quimilza (imsidolimab)
Vanda PharmaceuticalsNCT05352893 ↗
N R S
completed452023-08-17
People and roles

People, roles and programme history

The directors and officers of each company, the researchers who led its trials and the people the FDA addressed its letters to. Every name comes from an SEC filing, a company announcement, a trial registration or an FDA letter; rows from SEC filings and trial registrations link to their source. People at companies with an FDA decision on this board are listed first. Association with a programme does not establish responsibility for its outcome.

265named in SEC ownership filings
151directors
127officers
162have been an insider of more than one public company
5named researchers
4FDA letter recipients

The table has 280 rows, one for each named person: 265 from SEC ownership filings, 6 from company announcements, 5 researchers from trial registrations and 4 recipients of FDA letters. The rows name 277 distinct people, because 3 people appear twice, once from an SEC filing and once from a company announcement. The director and officer counts overlap, because 22 people hold both roles.

Programme history, not a success rate. An FDA decision belongs to an application and the programme behind it, not to a director or an officer. This view therefore reports the companies each person has been an insider of and the FDA decisions that fell inside their recorded tenure. It publishes no success rate for any person, because almost every person here has been through a single FDA decision at a single company, and a rate needs more than one. The Portfolio exposure view's team term counts the FDA approvals a whole team has been through at other companies, and rates no person.

Tenure. A person's tenure at a company starts on the date of their first SEC ownership filing for that company, which is the earliest date the SEC record shows them as a director, officer or ten percent holder. Decisions dated before that filing are excluded. The filing date does not establish when the person was hired, or that they worked on a particular drug.
Where the roles come from. A person files Form 3, 4 or 5 with the SEC themselves. The form states whether the filer is a director, whether they are an officer, and the job title the company gives them. The table shows each role in words. Select Source fields under a role to see the element exactly as it was filed.

Coverage limit. A career list is read from a person's Form 3 filings and is capped at 8 issuers per person. Where a person has more, the row says so rather than implying the list is complete. These lists cover US public companies only. Private companies, academic posts and anything before a person first became an insider of a registrant are not in a Form 3 and so are not here.
Coverage and exclusions. 18 of the companies on this board were read and 5 were not:
  • Arcellx, acquired by Gilead · the ticker resolves to no CIK in the SEC's own map, so this is a company this source cannot reach, not a company without officers
  • Daiichi Sankyo · the ticker resolves to no CIK in the SEC's own map, so this is a company this source cannot reach, not a company without officers
  • Jerini, acquired by Shire · the ticker resolves to no CIK in the SEC's own map, so this is a company this source cannot reach, not a company without officers
  • Novo Nordisk · this registrant files no Forms 3, 4 or 5. Foreign private issuers are exempt from Section 16, so no insider roster is published to read
  • Otsuka (Taiho) · the ticker resolves to no CIK in the SEC's own map, so this is a company this source cannot reach, not a company without officers
11 names on those registers are funds and other entities rather than people. They are counted as entities and are not listed as executives. 3 entries in the trial registry give a job title where a name should be, such as "Study Director, Pharvaris". They are excluded, because listing them would add researchers who cannot be identified.

Earlier public companies: the count, then the first five. No SEC filing: not in an SEC ownership filing here, which is not proof the person is not an insider. – no FDA decision during the recorded tenure. ↗ the person’s SEC filings on EDGAR, or the trial registry entry.

PersonKindCompany and role Earlier public companiesFDA decisions in tenureSource
Srinivas Akkarajudirector
Mineralys Director
Source fields<isDirector>1</isDirector>
· Lorundrostat (pending)
Scholar Rock Director
Source fields<isDirector>1</isDirector>
· Apitegromab (Isembyld) (approved)
8 or more
Graphite Bio, Inc., Scholar Rock Holding Corp, Mineralys Therapeutics, Inc., CARGO Therapeutics, Inc., vTv Therapeutics Inc., and more
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Daniel G Welchdirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
8 or more
HYPERION THERAPEUTICS INC, Corium International, Inc., Ultragenyx Pharmaceutical Inc., INTERCEPT PHARMACEUTICALS INC, AveXis, Inc., and more
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
David N Gilldirector
Telix Pharmaceuticals Director
Source fields<isDirector>1</isDirector>
· Pixclara (floretyrosine F 18) (approved)
8 or more
CEMPRA, INC., HISTOGENICS CORP, EndoChoice Holdings, Inc., Evolus, Inc., STRATA Skin Sciences, Inc., and more
Pixclara (floretyrosine F 18) approved, 2026-09-11
Pixclara (floretyrosine F 18) refused, 2025-04-25
↗
Kristina Burowdirector
Scholar Rock Director
Source fields<isDirector>true</isDirector>
· Apitegromab (Isembyld) (approved)
8 or more
Neumora Therapeutics, Inc., Boundless Bio, Inc., Rapport Therapeutics, Inc., Metsera, Inc., Maze Therapeutics, Inc., and more
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Matthew K Fustdirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
8 or more
ONYX PHARMACEUTICALS INC, Ultragenyx Pharmaceutical Inc., MACROGENICS INC, Dermira, Inc., Atara Biotherapeutics, Inc., and more
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Deborah Dunsiredirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
6
MILLENNIUM PHARMACEUTICALS INC, ALLERGAN INC, Ultragenyx Pharmaceutical Inc., ALEXION PHARMACEUTICALS INC, Syros Pharmaceuticals, Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Richard Brudnickdirector
Scholar Rock Director
Source fields<isDirector>1</isDirector>
· Apitegromab (Isembyld) (approved)
6
Bioverativ Inc., Codiak BioSciences, Inc., VOLITIONRX LTD, Prime Medicine, Inc., Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
William R Jellisondirector
Telix Pharmaceuticals Director
Source fields<isDirector>1</isDirector>
· Pixclara (floretyrosine F 18) (approved)
6
STRYKER CORP, POLYONE CORP, Anika Therapeutics, Inc., MASIMO CORP, Medtronic plc
Pixclara (floretyrosine F 18) approved, 2026-09-11
Pixclara (floretyrosine F 18) refused, 2025-04-25
↗
Corazon (Corsee) D. Sandersdirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
5
Molecular Templates, Inc., BeiGene, Ltd., Ultragenyx Pharmaceutical Inc., Legend Biotech Corp, Calidi Biotherapeutics, Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
David B Musketdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
5
CONOR MEDSYSTEMS INC, AEROGEN INC, MATRITECH INC/DE/, SPECTRX INC, CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
David Hallal
Chief Executive Officer
director and officer
Scholar Rock Director · Chief Executive Officer
Source fields<officerTitle>Chief Executive Officer</officerTitle>
· Apitegromab (Isembyld) (approved)
5
ALEXION PHARMACEUTICALS INC, Scholar Rock Holding Corp, iTeos Therapeutics, Inc., Allovir, Inc., Seer, Inc.
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Karah Herdman Parschauer
EVP and Chief Legal Officer
officer
Ultragenyx EVP and Chief Legal Officer
Source fields<officerTitle>EVP and Chief Legal Officer</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
5
Ultragenyx Pharmaceutical Inc., Arcturus Therapeutics Holdings Inc., Evolus, Inc., Anebulo Pharmaceuticals, Inc., Tenaya Therapeutics, Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Vikas Sinha
Chief Financial Officer
officer
Scholar Rock Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Apitegromab (Isembyld) (approved)
5
ALEXION PHARMACEUTICALS INC, Allovir, Inc., BCLS Acquisition Corp., Verona Pharma plc, Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Akshay Vaishnaw
President of R&D
director and officer
Scholar Rock Director · President of R&D
Source fields<officerTitle>President of R&D</officerTitle>
· Apitegromab (Isembyld) (approved)
4
ALNYLAM PHARMACEUTICALS, INC., Editas Medicine, Inc., Scholar Rock Holding Corp, Hemab Therapeutics Holdings, Inc.
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Erik Harris
EVP & Chief Commercial Officer
officer
Ultragenyx EVP & Chief Commercial Officer
Source fields<officerTitle>EVP & Chief Commercial Officer</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
4
Ultragenyx Pharmaceutical Inc., Denali Therapeutics Inc., Inozyme Pharma, Inc., Rezolute, Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Joshua Reeddirector
Scholar Rock Director
Source fields<isDirector>true</isDirector>
· Apitegromab (Isembyld) (approved)
4
Aldeyra Therapeutics, Inc., Scholar Rock Holding Corp, Omega Therapeutics, Inc., Alkermes plc.
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Keith Woods
Chief Operating Officer
officer
Scholar Rock Chief Operating Officer
Source fields<officerTitle>Chief Operating Officer</officerTitle>
· Apitegromab (Isembyld) (approved)
4
X4 Pharmaceuticals, Inc, TScan Therapeutics, Inc., ROCKET PHARMACEUTICALS, INC., Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Michael Narachidirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
4
ADVANCED MAGNETICS INC, Orexigen Therapeutics, Inc., Celladon Corp, Ultragenyx Pharmaceutical Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Shehnaaz Sulimandirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
4
Theravance Biopharma, Inc., Ultragenyx Pharmaceutical Inc., 10x Genomics, Inc., Alector, Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Earl M Collier JRdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
3
DECODE GENETICS INC, CAPRICOR THERAPEUTICS, INC., TESARO, Inc.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Eric Crombez
EVP and Chief Medical Officer
officer
Ultragenyx EVP and Chief Medical Officer
Source fields<officerTitle>EVP and Chief Medical Officer</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
3
Dimension Therapeutics, Inc., Ultragenyx Pharmaceutical Inc., ABEONA THERAPEUTICS INC.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Jing L. Marantz
CHIEF MEDICAL OFFICER
officer
Scholar Rock CHIEF MEDICAL OFFICER
Source fields<officerTitle>CHIEF MEDICAL OFFICER</officerTitle>
· Apitegromab (Isembyld) (approved)
3
Krystal Biotech, Inc., Arcturus Therapeutics Holdings Inc., Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Maria Rivasdirector
Telix Pharmaceuticals Director
Source fields<isDirector>1</isDirector>
· Pixclara (floretyrosine F 18) (approved)
3
Medidata Solutions, Inc., COOPER COMPANIES, INC., Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
Pixclara (floretyrosine F 18) refused, 2025-04-25
↗
Michael Gilmandirector
Scholar Rock Director
Source fields<isDirector>true</isDirector>
· Apitegromab (Isembyld) (approved)
3
BIOGEN IDEC INC, EPIX Pharmaceuticals, Inc., Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Amrit Raydirector
Ultragenyx Director
Source fields<isDirector>true</isDirector>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
2
Ultragenyx Pharmaceutical Inc., Fortrea Holdings Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Frank Litvackdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
2
CONOR MEDSYSTEMS INC, Nile Therapeutics, Inc.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
George W Dunbar JRdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
2
AASTROM BIOSCIENCES INC, CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Howard Horn
Chief Financial Officer
officer
Ultragenyx Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
2
Vir Biotechnology, Inc., Ultragenyx Pharmaceutical Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Katie Pengdirector
Scholar Rock Director
Source fields<isDirector>true</isDirector>
· Apitegromab (Isembyld) (approved)
2
Adicet Bio, Inc., Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Mike Kelliherdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
2
CAPRICOR THERAPEUTICS, INC., ARDELYX, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Philip J Gotwalsdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
2
CAPRICOR THERAPEUTICS, INC., OmniAb, Inc.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Anthony Bergmann
CHIEF FINANCIAL OFFICER
officer
Capricor CHIEF FINANCIAL OFFICER
Source fields<officerTitle>CHIEF FINANCIAL OFFICER</officerTitle>
· Deramiocel (excluded)
1
CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Caryn Parlavecchio
CHRO
officer
Scholar Rock CHRO
Source fields<officerTitle>CHRO</officerTitle>
· Apitegromab (Isembyld) (approved)
1
Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Dennis Karl Huang
See Remarks
officer
Ultragenyx See Remarks
Source fields<officerTitle>See Remarks</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
1
Ultragenyx Pharmaceutical Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Emil D Kakkis
President & CEO
director and officer
Ultragenyx Director · President & CEO
Source fields<officerTitle>President & CEO</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
1
Ultragenyx Pharmaceutical Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Jeffrey S. Flierdirector
Scholar Rock Director
Source fields<isDirector>true</isDirector>
· Apitegromab (Isembyld) (approved)
1
Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
John Richard Pinion
See Remarks
officer
Ultragenyx See Remarks
Source fields<officerTitle>See Remarks</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
1
Ultragenyx Pharmaceutical Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Junlin Ho
GENERAL COUNSEL
officer
Scholar Rock GENERAL COUNSEL
Source fields<officerTitle>GENERAL COUNSEL</officerTitle>
· Apitegromab (Isembyld) (approved)
1
Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Karen Krasney
EVP, GENERAL COUNSEL
officer
Capricor EVP, GENERAL COUNSEL
Source fields<officerTitle>EVP, GENERAL COUNSEL</officerTitle>
· Deramiocel (excluded)
1
CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Karimah Es Sabardirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
1
CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Linda Marban
CHIEF EXECUTIVE OFFICER
director and officer
Capricor Director · CHIEF EXECUTIVE OFFICER
Source fields<officerTitle>CHIEF EXECUTIVE OFFICER</officerTitle>
· Deramiocel (excluded)
1
CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Mo Qatanani
CHIEF SCIENTIFIC OFFICER
officer
Scholar Rock CHIEF SCIENTIFIC OFFICER
Source fields<officerTitle>CHIEF SCIENTIFIC OFFICER</officerTitle>
· Apitegromab (Isembyld) (approved)
1
Scholar Rock Holding Corp
Apitegromab (Isembyld) approved, 2026-09-11
Apitegromab (Isembyld) refused, 2025-09-22
↗
Paul Gisbert Auwaerterdirector
Capricor Director
Source fields<isDirector>true</isDirector>
· Deramiocel (excluded)
1
CAPRICOR THERAPEUTICS, INC.
Deramiocel refused, 2025-07-09
Deramiocel panel against, 2026-07-29
↗
Theodore Alan Huizenga
SVP, Chief Accounting Officer
officer
Ultragenyx SVP, Chief Accounting Officer
Source fields<officerTitle>SVP, Chief Accounting Officer</officerTitle>
· Fayuvi (rebisufligene etisparvovec-hopf) (approved)
1
Ultragenyx Pharmaceutical Inc.
Fayuvi (rebisufligene etisparvovec-hopf) refused, 2025-07-07
Fayuvi (rebisufligene etisparvovec-hopf) approved, 2026-09-17
↗
Ali Behbahaniten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
8 or more
Monte Rosa Therapeutics, Inc., Bright Health Group Inc., CVRx, Inc., MINERVA SURGICAL INC, Arcellx, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Carmen Changten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
8 or more
Metacrine, Inc., Savara Inc, Monte Rosa Therapeutics, Inc., Bright Health Group Inc., Coursera, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Ian T Clarkdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
8 or more
AVROBIO, Inc., Forty Seven, Inc., Guardant Health, Inc., Olema Pharmaceuticals, Inc., Kyverna Therapeutics, Inc., and more
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Paul Edward Walkerten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
8 or more
Metacrine, Inc., Trillium Therapeutics Inc., Savara Inc, Monte Rosa Therapeutics, Inc., Bright Health Group Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Anthony A. Florence Jr.ten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
7 or more
Arcellx, Inc., Senti Biosciences, Inc.\, ZeroFox Holdings, Inc., SYNLOGIC, INC., Korro Bio, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Edward T Mathersten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
7 or more
Monte Rosa Therapeutics, Inc., Bright Health Group Inc., Senti Biosciences, Inc.\, ObsEva SA, Korro Bio, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Forest Baskettten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
7 or more
Senti Biosciences, Inc.\, ZeroFox Holdings, Inc., Sagimet Biosciences Inc., SYNLOGIC, INC., Korro Bio, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Matthew Pauls
CHIEF EXECUTIVE OFFICER
director and officer
Savara Director · CHIEF EXECUTIVE OFFICER
Source fields<officerTitle>CHIEF EXECUTIVE OFFICER</officerTitle>
· Molgramostim (pending)
7
INSMED INC, Mast Therapeutics, Inc., Strongbridge Biopharma plc, Egalet Corp, SOLENO THERAPEUTICS INC
Molgramostim refused to file, 2025-05-27
↗
Mohamad Makhzoumiten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
7 or more
Berkshire Grey, Inc., IonQ, Inc., Arcellx, Inc., Senti Biosciences, Inc.\, Korro Bio, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Scott D Sandellten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
7 or more
Senti Biosciences, Inc.\, ZeroFox Holdings, Inc., Sagimet Biosciences Inc., SYNLOGIC, INC., Korro Bio, Inc., and more
Molgramostim refused to file, 2025-05-27
↗
Rick Yangten percent owner
Savara Ten percent owner
Source fields<isTenPercentOwner>true</isTenPercentOwner>
· Molgramostim (pending)
6
Savara Inc, Monte Rosa Therapeutics, Inc., Bright Health Group Inc., Korro Bio, Inc., MBX Biosciences, Inc.
Molgramostim refused to file, 2025-05-27
↗
Joseph S McCrackendirector
Savara Director
Source fields<isDirector>true</isDirector>
· Molgramostim (pending)
4
Nexvet Biopharma plc, Savara Inc, Kindred Biosciences, Inc., LUMOS PHARMA, INC.
Molgramostim refused to file, 2025-05-27
↗
Nevan C Elamdirector
Savara Director
Source fields<isDirector>true</isDirector>
· Molgramostim (pending)
4
NEKTAR THERAPEUTICS, AntriaBio, Inc., Savara Inc, Peak Bio, Inc.
Molgramostim refused to file, 2025-05-27
↗
Richard J Hawkinsdirector
Savara Director
Source fields<isDirector>true</isDirector>
· Molgramostim (pending)
4
SCICLONE PHARMACEUTICALS INC, CYTORI THERAPEUTICS, INC., Savara Inc, LUMOS PHARMA, INC.
Molgramostim refused to file, 2025-05-27
↗
David A Ramsaydirector
Savara Director
Source fields<isDirector>true</isDirector>
· Molgramostim (pending)
3
HALOZYME THERAPEUTICS INC, ADVENTRX PHARMACEUTICALS INC, LA JOLLA PHARMACEUTICAL CO
Molgramostim refused to file, 2025-05-27
↗
David L Lowrance
Chief Financial Officer
officer
Savara Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Molgramostim (pending)
3
CUMBERLAND PHARMACEUTICALS INC, ACUCELA INC., Savara Inc
Molgramostim refused to file, 2025-05-27
↗
Es-Johansson An vandirector
Savara Director
Source fields<isDirector>true</isDirector>
· Molgramostim (pending)
3
Savara Inc, PLUS THERAPEUTICS, INC., LUMOS PHARMA, INC.
Molgramostim refused to file, 2025-05-27
↗
Ricky Sundirector
Savara Director
Source fields<isDirector>true</isDirector>
· Molgramostim (pending)
3
Savara Inc, Arcutis Biotherapeutics, Inc., Annexon, Inc.
Molgramostim refused to file, 2025-05-27
↗
Robert Matthew Lutz
Chief Fin. & Operating Officer
officer
Savara Chief Fin. & Operating Officer
Source fields<officerTitle>Chief Fin. & Operating Officer</officerTitle>
· Molgramostim (pending)
3
Strongbridge Biopharma plc, iBio, Inc., Savara Inc
Molgramostim refused to file, 2025-05-27
↗
Raymond Dennis Pratt
Chief Medical Officer
officer
Savara Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Molgramostim (pending)
2
ROCKWELL MEDICAL TECHNOLOGIES INC, Savara Inc
Molgramostim refused to file, 2025-05-27
↗
Anne Erickson
Chief Business Officer
officer
Savara Chief Business Officer
Source fields<officerTitle>Chief Business Officer</officerTitle>
· Molgramostim (pending)
1
Savara Inc
Molgramostim refused to file, 2025-05-27
↗
Braden C. Parker
Chief Commercial Officer
officer
Savara Chief Commercial Officer
Source fields<officerTitle>Chief Commercial Officer</officerTitle>
· Molgramostim (pending)
1
Savara Inc
Molgramostim refused to file, 2025-05-27
↗
Kathleen R. McCabe
Chief Legal Officer
officer
Savara Chief Legal Officer
Source fields<officerTitle>Chief Legal Officer</officerTitle>
· Molgramostim (pending)
1
Savara Inc
Molgramostim refused to file, 2025-05-27
↗
Matt Pauls
CEO, Savara
person
Savara CEO, Savara
Source sentencehas served as Chair of the Board of Directors and Chief Executive Officer of Savara since 2020
· Molgramostim (pending)
no SEC filing
Molgramostim refused to file, 2025-05-27
Gabrielle Sulzbergerdirector
Eli Lilly Director
Source fields<isDirector>1</isDirector>
· Orforglipron (Foundayo) (approved)
8 or more
INDYMAC BANCORP INC, STAGE STORES INC, Brixmor Property Group Inc., TEVA PHARMACEUTICAL INDUSTRIES LTD, Mastercard Inc, and more
Orforglipron (Foundayo) approved, 2026-04-01
↗
John Maraganoredirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
8 or more
bluebird bio, Inc., AGIOS PHARMACEUTICALS INC, Beam Therapeutics Inc., Kymera Therapeutics, Inc., PROKIDNEY CORP., and more
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Ralph Alvarezdirector
Eli Lilly Director
Source fields<isDirector>1</isDirector>
· Orforglipron (Foundayo) (approved)
8
MCDONALDS CORP, KEYCORP /NEW/, LILLY ELI &amp; CO, LOWES COMPANIES INC, DUNKIN' BRANDS GROUP, INC.
Orforglipron (Foundayo) approved, 2026-04-01
↗
Steven Gillisdirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
8 or more
Boundless Bio, Inc., Rapport Therapeutics, Inc., Metsera, Inc., Maze Therapeutics, Inc., Lyell Immunopharma, Inc., and more
Oveporexton (Orzeyful) approved, 2026-08-05
↗
J Erik Fyrwalddirector
Eli Lilly Director
Source fields<isDirector>1</isDirector>
· Orforglipron (Foundayo) (approved)
6
LILLY ELI &amp; CO, Nalco Holding CO, ECOLAB INC, Univar Inc., Bunge LTD
Orforglipron (Foundayo) approved, 2026-04-01
↗
William D. Waddilldirector
Takeda and Protagonist Therapeutics Director
Source fields<isDirector>1</isDirector>
· Rusfertide (Mimrylo) (approved)
6
OncoMed Pharmaceuticals Inc, Calithera Biosciences, Inc., Protagonist Therapeutics, Inc, ARROWHEAD PHARMACEUTICALS, INC., Annexon, Inc.
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Bruce D Broussarddirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
5
HUMANA INC, KEYCORP /NEW/, HP INC, MARSH &amp; MCLENNAN COMPANIES, INC., TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Emiko Higashidirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
5
KLA TENCOR CORP, InvenSense Inc, RAMBUS INC, One Equity Partners Open Water I Corp., TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Jean Luc Buteldirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
5
MEDTRONIC INC, BAXTER INTERNATIONAL INC, VARIAN MEDICAL SYSTEMS INC, Rani Therapeutics Holdings, Inc., TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Lewis T Williamsdirector
Takeda and Protagonist Therapeutics Director
Source fields<isDirector>1</isDirector>
· Rusfertide (Mimrylo) (approved)
5
BECKMAN COULTER INC, FIVE PRIME THERAPEUTICS INC, Protagonist Therapeutics, Inc, Neoleukin Therapeutics, Inc., Arcellx, Inc.
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Arturo Molina MD
Chief Medical Officer
officer
Takeda and Protagonist Therapeutics Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Rusfertide (Mimrylo) (approved)
4
Cougar Biotechnology, Inc., SUTRO BIOPHARMA INC, Forma Therapeutics Holdings, Inc., Protagonist Therapeutics, Inc
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Harold E Selickdirector
Takeda and Protagonist Therapeutics Director
Source fields<isDirector>1</isDirector>
· Rusfertide (Mimrylo) (approved)
4
THRESHOLD PHARMACEUTICALS INC, PDL BIOPHARMA, INC., CATALYST BIOSCIENCES, INC., Protagonist Therapeutics, Inc
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Daniel Skovronsky
EVP, CS&PO & Pres. LRL
officer
Eli Lilly EVP, CS&PO & Pres. LRL
Source fields<officerTitle>EVP, CS&PO & Pres. LRL</officerTitle>
· Orforglipron (Foundayo) (approved)
3
LILLY ELI &amp; CO, MYRIAD GENETICS INC, ILLUMINA, INC.
Orforglipron (Foundayo) approved, 2026-04-01
↗
David A Ricks
President, Chair, and CEO
director and officer
Eli Lilly Director · President, Chair, and CEO
Source fields<officerTitle>President, Chair, and CEO</officerTitle>
· Orforglipron (Foundayo) (approved)
3
LILLY ELI &amp; CO, ADOBE SYSTEMS INC, Elanco Animal Health Inc
Orforglipron (Foundayo) approved, 2026-04-01
↗
Juan R Lucianodirector
Eli Lilly Director
Source fields<isDirector>1</isDirector>
· Orforglipron (Foundayo) (approved)
3
DOW CHEMICAL CO /DE/, ARCHER DANIELS MIDLAND CO, LILLY ELI &amp; CO
Orforglipron (Foundayo) approved, 2026-04-01
↗
Kimberly A. Reeddirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
3
Momentus Inc., Hannon Armstrong Sustainable Infrastructure Capital, Inc., TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Sarah A O'Dowddirector
Takeda and Protagonist Therapeutics Director
Source fields<isDirector>1</isDirector>
· Rusfertide (Mimrylo) (approved)
3
LAM RESEARCH CORP, ICHOR HOLDINGS, LTD., Protagonist Therapeutics, Inc
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Teresa Marie Bitetti
President, OBU
officer
Takeda President, OBU
Source fields<officerTitle>President, OBU</officerTitle>
· Oveporexton (Orzeyful) (approved)
3
Fusion Pharmaceuticals Inc., Aura Biosciences, Inc., TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Yoshiaki Fujimoridirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
3
BOSTON SCIENTIFIC CORP, Blaize Holdings, Inc., TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Anat Hakim
EVP, GC & Secretary
officer
Eli Lilly EVP, GC & Secretary
Source fields<officerTitle>EVP, GC & Secretary</officerTitle>
· Orforglipron (Foundayo) (approved)
2
WELLCARE HEALTH PLANS, INC., ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Bryan Giraudodirector
Takeda and Protagonist Therapeutics Director
Source fields<isDirector>1</isDirector>
· Rusfertide (Mimrylo) (approved)
2
Protagonist Therapeutics, Inc, Gossamer Bio, Inc.
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Christophe Pierre Weber
President and CEO
director and officer
Takeda Director · President and CEO
Source fields<officerTitle>President and CEO</officerTitle>
· Oveporexton (Orzeyful) (approved)
2
BOSTON SCIENTIFIC CORP, TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Lucas Montarce
EVP & CFO
officer
Eli Lilly EVP & CFO
Source fields<officerTitle>EVP & CFO</officerTitle>
· Orforglipron (Foundayo) (approved)
2
Elanco Animal Health Inc, ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Naarden Jacob Van
EVP,Pres LLY Oncology&HdCorpBD
officer
Eli Lilly EVP,Pres LLY Oncology&HdCorpBD
Source fields<officerTitle>EVP,Pres LLY Oncology&HdCorpBD</officerTitle>
· Orforglipron (Foundayo) (approved)
2
Loxo Oncology, Inc., ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Paulus Stoffelsdirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
2
JOHNSON &amp; JOHNSON, TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Adrienne S Brown
EVP, President LLY Imm
officer
Eli Lilly EVP, President LLY Imm
Source fields<officerTitle>EVP, President LLY Imm</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Agosti Marcello Pignagnoli
Head, Strat. & Port. Dev
officer
Takeda Head, Strat. & Port. Dev
Source fields<officerTitle>Head, Strat. & Port. Dev</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Andrew Stewart Plump
President, R&D
director and officer
Takeda Director · President, R&D
Source fields<officerTitle>President, R&D</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Asif Ali
Chief Financial Officer
officer
Takeda and Protagonist Therapeutics Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Rusfertide (Mimrylo) (approved)
1
Protagonist Therapeutics, Inc
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Asuka Miyabashira
President, Japan Pharma B.U.
officer
Takeda President, Japan Pharma B.U.
Source fields<officerTitle>President, Japan Pharma B.U.</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Awny Samaan Botros Farajallah
Chief Medical Officer
officer
Takeda Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Christian Behrenbruch
MD & Group CEO
director and officer
Telix Pharmaceuticals Director · MD & Group CEO
Source fields<officerTitle>MD & Group CEO</officerTitle>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
Darren Charlton Smith
Group Chief Financial Officer
officer
Telix Pharmaceuticals Group Chief Financial Officer
Source fields<officerTitle>Group Chief Financial Officer</officerTitle>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
Darren Joel Patti
Group Chief Operating Officer
officer
Telix Pharmaceuticals Group Chief Operating Officer
Source fields<officerTitle>Group Chief Operating Officer</officerTitle>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
David Norman Cade
Group Chief Medical Officer
officer
Telix Pharmaceuticals Group Chief Medical Officer
Source fields<officerTitle>Group Chief Medical Officer</officerTitle>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
Dinesh V PH D Patel
President and CEO
director and officer
Takeda and Protagonist Therapeutics Director · President and CEO
Source fields<officerTitle>President and CEO</officerTitle>
· Rusfertide (Mimrylo) (approved)
1
Protagonist Therapeutics, Inc
Rusfertide (Mimrylo) approved, 2026-08-28
↗
Diogo Rau
EVP & CIDO
officer
Eli Lilly EVP & CIDO
Source fields<officerTitle>EVP & CIDO</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Donald A Zakrowski
SVP, Finance, & CAO
officer
Eli Lilly SVP, Finance, & CAO
Source fields<officerTitle>SVP, Finance, & CAO</officerTitle>
· Orforglipron (Foundayo) (approved)
1
LILLY ELI &amp; CO
Orforglipron (Foundayo) approved, 2026-04-01
↗
Edgardo Hernandez
EVP & Pres., Mfg. Operations
officer
Eli Lilly EVP & Pres., Mfg. Operations
Source fields<officerTitle>EVP & Pres., Mfg. Operations</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Elaine Mary Shannon
Pres., Global Supply & Quality
officer
Takeda Pres., Global Supply & Quality
Source fields<officerTitle>Pres., Global Supply & Quality</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Eric Dozier
EVP, Chief People Officer
officer
Eli Lilly EVP, Chief People Officer
Source fields<officerTitle>EVP, Chief People Officer</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Gabriele Ricci
Chief Data & Tech. Officer
officer
Takeda Chief Data & Tech. Officer
Source fields<officerTitle>Chief Data & Tech. Officer</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Giles Richard Platford
President, IBU
officer
Takeda President, IBU
Source fields<officerTitle>President, IBU</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Ilya Yuffa
EVP&Pres, LLY USA&Global Capab
officer
Eli Lilly EVP&Pres, LLY USA&Global Capab
Source fields<officerTitle>EVP&Pres, LLY USA&Global Capab</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Jann Elizabeth Skinnerdirector
Telix Pharmaceuticals Director
Source fields<isDirector>1</isDirector>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
Jennifer Marie Smoter
Chief Comm. & Gov. Officer
officer
Takeda Chief Comm. & Gov. Officer
Source fields<officerTitle>Chief Comm. & Gov. Officer</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Julie So-Young Kim
President and CEO
director and officer
Takeda Director · President and CEO
Source fields<officerTitle>President and CEO</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Kenneth L. Custer
EVP & President, Card Met Hlth
officer
Eli Lilly EVP & President, Card Met Hlth
Source fields<officerTitle>EVP & President, Card Met Hlth</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Koichiro Kimuradirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Koji Hatsukawadirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Lauren Rusckowski Duprey
Chief Transformation Officer
officer
Takeda Chief Transformation Officer
Source fields<officerTitle>Chief Transformation Officer</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Mani Sharma
See Remarks
officer
AstraZeneca See Remarks
Source fields<officerTitle>See Remarks</officerTitle>
· Baxdrostat (Baxfendy) (approved)
1
ASTRAZENECA PLC
Baxdrostat (Baxfendy) approved, 2026-05-15
↗
Marie Elizabeth McDonalddirector
Telix Pharmaceuticals Director
Source fields<isDirector>1</isDirector>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
Mark Alexander Nelsondirector
Telix Pharmaceuticals Director
Source fields<isDirector>1</isDirector>
· Pixclara (floretyrosine F 18) (approved)
1
Telix Pharmaceuticals Ltd
Pixclara (floretyrosine F 18) approved, 2026-09-11
↗
Masami Iijimadirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Melissa Seymour
EVP, Global Quality
officer
Eli Lilly EVP, Global Quality
Source fields<officerTitle>EVP, Global Quality</officerTitle>
· Orforglipron (Foundayo) (approved)
1
ELI LILLY &amp; Co
Orforglipron (Foundayo) approved, 2026-04-01
↗
Michael T Maurer
CHIEF COMMERCIAL OFFICER
officer
Capricor CHIEF COMMERCIAL OFFICER
Source fields<officerTitle>CHIEF COMMERCIAL OFFICER</officerTitle>
· Deramiocel (excluded)
1
CAPRICOR THERAPEUTICS, INC.
Deramiocel panel against, 2026-07-29
↗
Michel Bruno Orsingerdirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Miki Tsusakadirector
Takeda Director
Source fields<isDirector>1</isDirector>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Milano Furuta
Chief Financial Officer
director and officer
Takeda Director · Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Natalie Anne Marie Furney
Global General Counsel
officer
Takeda Global General Counsel
Source fields<officerTitle>Global General Counsel</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Nicola Deidre Petal Greenway
Chief Human Resources Officer
officer
Takeda Chief Human Resources Officer
Source fields<officerTitle>Chief Human Resources Officer</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Patrik Jonsson
EVP & President, LLY Int'l
officer
Eli Lilly EVP & President, LLY Int'l
Source fields<officerTitle>EVP & President, LLY Int'l</officerTitle>
· Orforglipron (Foundayo) (approved)
1
LILLY ELI &amp; CO
Orforglipron (Foundayo) approved, 2026-04-01
↗
Ramy Riad Ahmed Ibrahim
President, PDT BU
officer
Takeda President, PDT BU
Source fields<officerTitle>President, PDT BU</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Rhonda Janice Pacheco
President, U.S. Business Unit
officer
Takeda President, U.S. Business Unit
Source fields<officerTitle>President, U.S. Business Unit</officerTitle>
· Oveporexton (Orzeyful) (approved)
1
TAKEDA PHARMACEUTICAL CO LTD
Oveporexton (Orzeyful) approved, 2026-08-05
↗
Arlene Morrisdirector
Cogent Bio Director
Source fields<isDirector>true</isDirector>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
8 or more
AFFYMAX INC, Biodel Inc, PALATIN TECHNOLOGIES INC, Dimension Therapeutics, Inc., VIVEVE MEDICAL, INC., and more
–↗
Peter Evan Harwindirector
Cogent Bio Director
Source fields<isDirector>true</isDirector>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
8 or more
Aeglea BioTherapeutics, Inc., Dianthus Therapeutics, Inc. /DE/, Oruka Therapeutics, Inc., Zenas BioPharma, Inc., Jade Biosciences, Inc., and more
–↗
Karen Jean Ferrantedirector
Cogent Bio Director
Source fields<isDirector>true</isDirector>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
5
PROGENICS PHARMACEUTICALS INC, Tokai Pharmaceuticals Inc, Baxalta Inc, MACROGENICS INC, Unum Therapeutics, Inc.
–↗
Andrew R Robbins
President and CEO
director and officer
Cogent Bio Director · President and CEO
Source fields<officerTitle>President and CEO</officerTitle>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
4
ARRAY BIOPHARMA INC, Harpoon Therapeutics, Inc., TURMERIC ACQUISITION CORP., Cogent Biosciences, Inc.
–↗
Christopher W. Caindirector
Cogent Bio Director
Source fields<isDirector>true</isDirector>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
4
Unum Therapeutics Inc., Viridian Therapeutics, Inc.\DE, Jade Biosciences, Inc., Galecto, Inc.
–↗
Matthew Rosdirector
Cogent Bio Director
Source fields<isDirector>true</isDirector>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
3
Epizyme, Inc., Unum Therapeutics Inc., Verastem, Inc.
–↗
Todd Shegogdirector
Cogent Bio Director
Source fields<isDirector>true</isDirector>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
3
SYNLOGIC, INC., Forma Therapeutics Holdings, Inc.,, Cogent Biosciences, Inc.
–↗
Evan Kearns
Chief Legal Officer
officer
Cogent Bio Chief Legal Officer
Source fields<officerTitle>Chief Legal Officer</officerTitle>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
2
AGENUS INC, Cogent Biosciences, Inc.
–↗
John L. Green
Chief Financial Officer
officer
Cogent Bio Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
2
MERRIMACK PHARMACEUTICALS INC, Unum Therapeutics Inc.
–↗
Cole Pinnow
Chief Commercial Officer
officer
Cogent Bio Chief Commercial Officer
Source fields<officerTitle>Chief Commercial Officer</officerTitle>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
1
Cogent Biosciences, Inc.
–↗
Jessica Sachs
Chief Medical Officer
officer
Cogent Bio Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
1
Unum Therapeutics Inc.
–↗
John Edward Robinson
Chief Scientific Officer
officer
Cogent Bio Chief Scientific Officer
Source fields<officerTitle>Chief Scientific Officer</officerTitle>
· Bezuclastinib (pending), Bezuclastinib (NonAdvSM) (pending), Bezuclastinib (AdvSM) (pending)
1
Cogent Biosciences, Inc.
–↗
Charles J Homcydirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
8 or more
CEPHALON INC, PORTOLA PHARMACEUTICALS INC, Global Blood Therapeutics, Inc., MyoKardia Inc, BridgeBio Pharma, Inc., and more
–↗
Eric Aguiardirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
8 or more
REPLIDYNE INC, HEALTHCARE ACQUISITION CORP, Ocera Therapeutics, Inc., Invitae Corp, Biohaven Pharmaceutical Holding Co Ltd., and more
–↗
Fred Hassandirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
8 or more
TIME WARNER INC., Valeant Pharmaceuticals International, Inc., AMGEN INC, INTREXON CORP, Prometheus Biosciences, Inc., and more
–↗
Andrew Lodirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
7
Axovant Sciences Ltd., Arbutus Biopharma Corp, Myovant Sciences Ltd., Urovant Sciences Ltd., BridgeBio Pharma, Inc.
–↗
James C Momtazeedirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
7 or more
JAZZ PHARMACEUTICALS INC, HCA INC/TN, PRA Health Sciences, Inc., ENTELLUS MEDICAL INC, BridgeBio Pharma, Inc., and more
–↗
Frank Mccormickdirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
5
EXELIXIS INC, ADURO BIOTECH, INC., BridgeBio Pharma, Inc., Olema Pharmaceuticals, Inc., BridgeBio Oncology Therapeutics, Inc.
–↗
Neil Kumar
Chief Executive Officer
director and officer
BridgeBio Director · Chief Executive Officer
Source fields<officerTitle>Chief Executive Officer</officerTitle>
· BBP-418 (pending), Infigratinib (pending)
5
Eidos Therapeutics, Inc., BridgeBio Pharma, Inc., LianBio, BridgeBio Oncology Therapeutics, Inc., Maze Therapeutics, Inc.
–↗
Randal W. Scottdirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
5
GENOMIC HEALTH INC, Invitae Corp, BridgeBio Pharma, Inc., Talis Biomedical Corp, Freenome, Inc.
–↗
Ali J. Satvatdirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
4
Coherus BioSciences, Inc., Eidos Therapeutics, Inc., BridgeBio Pharma, Inc., IMPEL NEUROPHARMA INC
–↗
Douglas A. Dachilledirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
4
AMERICAN INTERNATIONAL GROUP INC, BridgeBio Pharma, Inc., PNC FINANCIAL SERVICES GROUP, INC., Equitable Holdings, Inc.
–↗
Hannah Valantinedirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
3
PACIFIC BIOSCIENCES OF CALIFORNIA, INC., CareDx, Inc., BridgeBio Pharma, Inc.
–↗
Jennifer E. Cookdirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
3
Denali Therapeutics Inc., BridgeBio Pharma, Inc., Jazz Pharmaceuticals plc
–↗
Andrea Ellisdirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
1
BridgeBio Pharma, Inc.
–↗
Maricel Apuli
Chief Accounting Officer
officer
BridgeBio Chief Accounting Officer
Source fields<officerTitle>Chief Accounting Officer</officerTitle>
· BBP-418 (pending), Infigratinib (pending)
1
BridgeBio Pharma, Inc.
–↗
Ronald J Danielsdirector
BridgeBio Director
Source fields<isDirector>1</isDirector>
· BBP-418 (pending), Infigratinib (pending)
1
BridgeBio Pharma, Inc.
–↗
Thomas Trimarchi
President and CFO
officer
BridgeBio President and CFO
Source fields<officerTitle>President and CFO</officerTitle>
· BBP-418 (pending), Infigratinib (pending)
1
BridgeBio Pharma, Inc.
–↗
Andrew R Allendirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
8
PHARMION CORP, Clovis Oncology, Inc., Epizyme, Inc., Sierra Oncology, Inc., Gritstone Oncology, Inc.
–↗
Athena Countouriotisdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
8
AMBIT BIOSCIENCES CORP, HALOZYME THERAPEUTICS INC, Adverum Biotechnologies, Inc., Trovagene, Inc., Turning Point Therapeutics, Inc.
–↗
Barbara W. Bodemdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
8
INVACARE CORP, Hill-Rom Holdings, Inc., Turning Point Therapeutics, Inc., Syneos Health, Inc., Enovis CORP
–↗
Fred E Cohendirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
8 or more
VERACYTE, INC., TANDEM DIABETES CARE INC, CareDx, Inc., Roka BioScience, Inc., UroGen Pharma Ltd., and more
–↗
Mary Thistledirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
8
VIACELL INC, Dimension Therapeutics, Inc., Homology Medicines, Inc., ZIOPHARM ONCOLOGY INC, Entrada Therapeutics, Inc.
–↗
Robert J. Hombachdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
8
BAXTER INTERNATIONAL INC, Baxalta Inc, BIOMARIN PHARMACEUTICAL INC, CARMAX INC, Aptinyx Inc.
–↗
Stephen W Websterdirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
8 or more
Spark Therapeutics, Inc., Viking Therapeutics, Inc., Nabriva Therapeutics AG, NextCure, Inc., TCR2 THERAPEUTICS INC., and more
–↗
Timothy P Walbertdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
8 or more
Aurinia Pharmaceuticals Inc., Century Therapeutics, Inc., Mirum Pharmaceuticals, Inc., Sagimet Biosciences Inc., BIOMARIN PHARMACEUTICAL INC, and more
–↗
David D. Meekdirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
7
ENDOCYTE INC, Baxalta Inc, uniQure N.V., Entasis Therapeutics Holdings Inc., Mirati Therapeutics, Inc.
–↗
Glenn Sblendoriodirector
Mineralys Director
Source fields<isDirector>1</isDirector>
· Lorundrostat (pending)
7
EYETECH PHARMACEUTICALS INC, MEDICINES CO /DE, AMICUS THERAPEUTICS INC, Ophthotech Corp., INTERCEPT PHARMACEUTICALS INC
–↗
Mark J Enyedydirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
7
FATE THERAPEUTICS INC, IMMUNOGEN INC, KERYX BIOPHARMACEUTICALS INC, Akebia Therapeutics, Inc., LogicBio Therapeutics, Inc.
–↗
Willard H Deredirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
7
AMGEN INC, Radius Health, Inc., BIOMARIN PHARMACEUTICAL INC, Ocera Therapeutics, Inc., Seres Therapeutics, Inc.
–↗
Derek DiRoccodirector
Mineralys Director
Source fields<isDirector>1</isDirector>
· Lorundrostat (pending)
6
89bio, Inc., iTeos Therapeutics, Inc., Werewolf Therapeutics, Inc., Acrivon Therapeutics, Inc., Mineralys Therapeutics, Inc.
–↗
Richard A Meierdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
6
BIOMARIN PHARMACEUTICAL INC, STAAR SURGICAL CO, TELEFLEX INC, OWENS &amp; MINOR INC/VA/, Intersect ENT, Inc.
–↗
Brian Goffdirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
5
IDENIX PHARMACEUTICALS INC, Baxalta Inc, ALEXION PHARMACEUTICALS INC, AGIOS PHARMACEUTICALS, INC., Intellia Therapeutics, Inc.
–↗
Daphne Karydasdirector
Mineralys Director
Source fields<isDirector>1</isDirector>
· Lorundrostat (pending)
5
Syndax Pharmaceuticals Inc, Eucrates Biomedical Acquisition Corp., LogicBio Therapeutics, Inc., Mineralys Therapeutics, Inc., COMPASS Pathways plc
–↗
John M Leonard
President and CEO
director and officer
Intellia Director · President and CEO
Source fields<officerTitle>President and CEO</officerTitle>
· Lonvo-z (pending)
5
AbbVie Inc., CHIMERIX INC, Quintiles Transnational Holdings Inc., Vitae Pharmaceuticals, Inc, Intellia Therapeutics, Inc.
–↗
Maykin Hodirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
5
AGIOS PHARMACEUTICALS INC, PAREXEL INTERNATIONAL CORP, FIBROGEN INC, BIOMARIN PHARMACEUTICAL INC, Neumora Therapeutics, Inc.
–↗
David E I Pyottdirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
4
ALNYLAM PHARMACEUTICALS, INC., BIOMARIN PHARMACEUTICAL INC, PLIANT THERAPEUTICS, INC., Tarsus Pharmaceuticals, Inc.
–↗
Frank Verwieldirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
4
INTERMUNE INC, ACHILLION PHARMACEUTICALS INC, AveXis, Inc., Intellia Therapeutics, Inc.
–↗
Henry J Fuchs
President, Worldwide R&D
officer
BioMarin President, Worldwide R&D
Source fields<officerTitle>President, Worldwide R&D</officerTitle>
· Vosoritide (Voxzogo) (pending)
4
ONYX PHARMACEUTICALS INC, BIOMARIN PHARMACEUTICAL INC, Mirati Therapeutics, Inc., GENOMIC HEALTH INC
–↗
Jon Congleton
Chief Executive Officer
director and officer
Mineralys Director · Chief Executive Officer
Source fields<officerTitle>Chief Executive Officer</officerTitle>
· Lorundrostat (pending)
4
Nivalis Therapeutics, Inc., Mineralys Therapeutics, Inc., IMMUNIC, INC., Avalyn Pharma Inc.
–↗
Mary Kay Fenton
Chief Financial Officer
officer
Cullinan Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
4
ACHILLION PHARMACEUTICALS INC, Oncorus, Inc., Talaris Therapeutics, Inc., Cullinan Therapeutics, Inc.
–↗
Muna Bhanjidirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
4
CYTOKINETICS INC, ARDELYX, INC., VERACYTE, INC., Intellia Therapeutics, Inc.
–↗
Nadim Ahmed
President and CEO
director and officer
Cullinan Director · President and CEO
Source fields<officerTitle>President and CEO</officerTitle>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
4
CELGENE CORP /DE/, BRISTOL MYERS SQUIBB CO, Cullinan Oncology, Inc., Disc Medicine, Inc.
–↗
Adam Scott Levy
CFO and Secretary
officer
Mineralys CFO and Secretary
Source fields<officerTitle>CFO and Secretary</officerTitle>
· Lorundrostat (pending)
3
MIRAGEN THERAPEUTICS, INC., Brickell Biotech, Inc., Mineralys Therapeutics, Inc.
–↗
Anthony Rosenbergdirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
3
IDENIX PHARMACEUTICALS INC, Radius Health, Inc., Cullinan Management, Inc.
–↗
David W. Nassif
CFO / CLO
officer
Pharvaris CFO / CLO
Source fields<officerTitle>CFO / CLO</officerTitle>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
3
SteadyMed Ltd., Axovant Gene Therapies Ltd., Pharvaris N.V.
–↗
Elizabeth M Andersondirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
3
INSMED Inc, BIOMARIN PHARMACEUTICAL INC, Revolution Medicines, Inc.
–↗
Georgia Kerestydirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
3
ASPEN TECHNOLOGY INC /DE/, Solid Biosciences Inc., Intellia Therapeutics, Inc.
–↗
James J. Ferguson III
Chief Medical Officer
officer
Mineralys Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Lorundrostat (pending)
3
Matinas BioPharma Holdings, Inc., Cadrenal Therapeutics, Inc., Mineralys Therapeutics, Inc.
–↗
Mittie Doyledirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
3
DICE Therapeutics, Inc., Avalo Therapeutics, Inc., Cullinan Therapeutics, Inc.
–↗
Robert M Plengedirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
3
Translate Bio, Inc., BRISTOL MYERS SQUIBB CO, BIOMARIN PHARMACEUTICAL INC
–↗
Viviane Mongesdirector
Pharvaris Director
Source fields<isDirector>true</isDirector>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
3
DBV Technologies S.A., ADC Therapeutics SA, Pharvaris N.V.
–↗
William J Chasedirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
3
AbbVie Inc., Intellia Therapeutics, Inc., GRAIL, LLC
–↗
Berndt Modig
Chief Executive Officer
director and officer
Pharvaris Director · Chief Executive Officer
Source fields<officerTitle>Chief Executive Officer</officerTitle>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
2
Axovant Sciences Ltd., Pharvaris N.V.
–↗
Brian Mueller
EVP, Chief Financial Officer
officer
BioMarin EVP, Chief Financial Officer
Source fields<officerTitle>EVP, Chief Financial Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
2
BIOMARIN PHARMACEUTICAL INC, Anthera Pharmaceuticals Inc
–↗
David Malcom Rodman
Chief Medical Officer
officer
Mineralys Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Lorundrostat (pending)
2
Nivalis Therapeutics, Inc., Mineralys Therapeutics, Inc.
–↗
Edward J Dulac III
EVP, Chief Financial Officer
officer
Intellia EVP, Chief Financial Officer
Source fields<officerTitle>EVP, Chief Financial Officer</officerTitle>
· Lonvo-z (pending)
2
FATE THERAPEUTICS INC, Intellia Therapeutics, Inc.
–↗
Elaine J Herondirector
BioMarin Director
Source fields<isDirector>1</isDirector>
· Vosoritide (Voxzogo) (pending)
2
Vaxart, Inc., PALVELLA THERAPEUTICS, INC.
–↗
Elisabeth Bjorkdirector
Pharvaris Director
Source fields<isDirector>true</isDirector>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
2
ROCKET PHARMACEUTICALS, INC., Pharvaris N.V.
–↗
Eric Warren
Chief Commercial Officer
officer
Mineralys Chief Commercial Officer
Source fields<officerTitle>Chief Commercial Officer</officerTitle>
· Lorundrostat (pending)
2
Esperion Therapeutics, Inc., Mineralys Therapeutics, Inc.
–↗
Erin Burkhart
GVP, Chief Accounting Officer
officer
BioMarin GVP, Chief Accounting Officer
Source fields<officerTitle>GVP, Chief Accounting Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
2
BIOMARIN PHARMACEUTICAL INC, GILEAD SCIENCES, INC.
–↗
Jacquelyn L Sumer
Chief Legal Officer
officer
Cullinan Chief Legal Officer
Source fields<officerTitle>Chief Legal Officer</officerTitle>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
2
GENOCEA BIOSCIENCES, INC., Cullinan Oncology, Inc.
–↗
James Basta
EVP, General Counsel
officer
Intellia EVP, General Counsel
Source fields<officerTitle>EVP, General Counsel</officerTitle>
· Lonvo-z (pending)
2
Kura Oncology, Inc., Intellia Therapeutics, Inc.
–↗
Jesse Goodmandirector
Intellia Director
Source fields<isDirector>true</isDirector>
· Lonvo-z (pending)
2
Intellia Therapeutics, Inc., BiomX Inc.
–↗
Alexander Hardy
Chief Executive Officer
director and officer
BioMarin Director · Chief Executive Officer
Source fields<officerTitle>Chief Executive Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
1
BIOMARIN PHARMACEUTICAL INC
–↗
Alexander M Golddirector
Mineralys Director
Source fields<isDirector>1</isDirector>
· Lorundrostat (pending)
1
Mineralys Therapeutics, Inc.
–↗
Anna Nijdam
Principal Accounting Officer
officer
Pharvaris Principal Accounting Officer
Source fields<officerTitle>Principal Accounting Officer</officerTitle>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
1
Pharvaris N.V.
–↗
Anne Lesage
Chief Early Development
officer
Pharvaris Chief Early Development
Source fields<officerTitle>Chief Early Development</officerTitle>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
1
Pharvaris N.V.
–↗
Anne-Marie Martindirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
1
Cullinan Oncology, Inc.
–↗
Birgit C Schultes
EVP, Chief Scientific Officer
officer
Intellia EVP, Chief Scientific Officer
Source fields<officerTitle>EVP, Chief Scientific Officer</officerTitle>
· Lonvo-z (pending)
1
Intellia Therapeutics, Inc.
–↗
Brian Taylor Slingsbydirector
Mineralys Director
Source fields<isDirector>1</isDirector>
· Lorundrostat (pending)
1
Mineralys Therapeutics, Inc.
–↗
Charles Greg Guyer
EVP, Chief Technical Officer
officer
BioMarin EVP, Chief Technical Officer
Source fields<officerTitle>EVP, Chief Technical Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
1
BIOMARIN PHARMACEUTICAL INC
–↗
Corrine Savill
Chief Business Officer
officer
Cullinan Chief Business Officer
Source fields<officerTitle>Chief Business Officer</officerTitle>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
1
Cullinan Management, Inc.
–↗
Cristin Hubbard
EVP, Chief Commercial Officer
officer
BioMarin EVP, Chief Commercial Officer
Source fields<officerTitle>EVP, Chief Commercial Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
1
BIOMARIN PHARMACEUTICAL INC
–↗
David Lebwohl
EVP, Chief Medical Officer
officer
Intellia EVP, Chief Medical Officer
Source fields<officerTitle>EVP, Chief Medical Officer</officerTitle>
· Lonvo-z (pending)
1
Intellia Therapeutics, Inc.
–↗
David P. Ryandirector
Cullinan Director
Source fields<isDirector>true</isDirector>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
1
Cullinan Oncology, Inc.
–↗
Eliana Clark
EVP, Chief Technical Officer
officer
Intellia EVP, Chief Technical Officer
Source fields<officerTitle>EVP, Chief Technical Officer</officerTitle>
· Lonvo-z (pending)
1
Intellia Therapeutics, Inc.
–↗
Gary Clark Biddledirector
Belite Bio Director
Source fields<isDirector>true</isDirector>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
George Eric Davis
EVP, Chief Legal Officer
officer
BioMarin EVP, Chief Legal Officer
Source fields<officerTitle>EVP, Chief Legal Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
1
BIOMARIN PHARMACEUTICAL INC
–↗
Gregory R Friberg
EVP, Chief R&D Officer
officer
BioMarin EVP, Chief R&D Officer
Source fields<officerTitle>EVP, Chief R&D Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
1
BIOMARIN PHARMACEUTICAL INC
–↗
Hao-Yuan Chuang
Chief Financial Officer
director and officer
Belite Bio Director · Chief Financial Officer
Source fields<officerTitle>Chief Financial Officer</officerTitle>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Hendrik Peter Scholl
Chief Medical Officer
officer
Belite Bio Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Ita Ludirector
Belite Bio Director
Source fields<isDirector>true</isDirector>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Jeffrey Alan Jones
Chief Medical Officer
officer
Cullinan Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
1
Cullinan Oncology, Inc.
–↗
Jennifer Michaelson
Chief Scientific Officer
officer
Cullinan Chief Scientific Officer
Source fields<officerTitle>Chief Scientific Officer</officerTitle>
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
1
Cullinan Management, Inc.
–↗
Johannes Gerardus Christiaan Petrus Schikandirector
Pharvaris Director
Source fields<isDirector>true</isDirector>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
1
Pharvaris N.V.
–↗
John Michael Longodirector
Belite Bio Director
Source fields<isDirector>true</isDirector>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Michael P Dube
VP, Chief Accounting Officer
officer
Intellia VP, Chief Accounting Officer
Source fields<officerTitle>VP, Chief Accounting Officer</officerTitle>
· Lonvo-z (pending)
1
Intellia Therapeutics, Inc.
–↗
Nathan L. Mata
Chief Scientific Officer
officer
Belite Bio Chief Scientific Officer
Source fields<officerTitle>Chief Scientific Officer</officerTitle>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Peng Lu
President
officer
Pharvaris President
Source fields<officerTitle>President</officerTitle>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
1
Pharvaris N.V.
–↗
Rashmi Virendra Ramchandani
VP, Chief Accounting Officer
officer
BioMarin VP, Chief Accounting Officer
Source fields<officerTitle>VP, Chief Accounting Officer</officerTitle>
· Vosoritide (Voxzogo) (pending)
1
BIOMARIN PHARMACEUTICAL INC
–↗
Robert Glassmandirector
Pharvaris Director
Source fields<isDirector>true</isDirector>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
1
Pharvaris N.V.
–↗
Wan-Shan Chendirector
Belite Bio Director
Source fields<isDirector>true</isDirector>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Wim Souverijns
Chief Commercial Officer
officer
Pharvaris Chief Commercial Officer
Source fields<officerTitle>Chief Commercial Officer</officerTitle>
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
1
Pharvaris N.V.
–↗
Xiao-Hui Chendirector
Belite Bio Director
Source fields<isDirector>true</isDirector>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Yasmine Wasfi
Chief Medical Officer
officer
Savara Chief Medical Officer
Source fields<officerTitle>Chief Medical Officer</officerTitle>
· Molgramostim (pending)
1
Savara Inc
–↗
Yu-Hsin Lin
Chief Executive Officer
director and officer
Belite Bio Director · Chief Executive Officer
Source fields<officerTitle>Chief Executive Officer</officerTitle>
· Tinlarebant (pending)
1
BELITE BIO, INC
–↗
Berndt Modig
CEO, Pharvaris
person
Pharvaris CEO, Pharvaris
Source sentenceco-founded Pharvaris and has served as Chief Executive Officer since its inception
· Deucrictibant IR (pending), Deucrictibant XR (not_filed)
no SEC filing–
Jochen Knolle
Co-founder and strategic advisor, Pharvaris; CSO and COO to end
person
Pharvaris Co-founder and strategic advisor, Pharvaris; CSO and COO to end 2023
Source sentenceDr. Knolle, who served as Chief Scientific Officer and Chief Operating Officer since the Company's inception up to September 30, 2023
· role ended 30 September 2023 · Deucrictibant IR (pending), Deucrictibant XR (not_filed)
no SEC filing–
John Leonard
CEO, Intellia
person
Intellia CEO, Intellia
Source sentenceIntellia Therapeutics names John Leonard, M.D., President and Chief Executive Officer
· Lonvo-z (pending)
no SEC filing–
Jon Congleton
CEO, Mineralys
person
Mineralys CEO, Mineralys
Source sentencehas served as Chief Executive Officer and as a member of the Board since November 2020
· Lorundrostat (pending)
no SEC filing–
Nadim Ahmed
CEO, Cullinan
person
Cullinan CEO, Cullinan
Source sentenceCullinan Oncology appoints Nadim Ahmed as Chief Executive Officer
· Zipalertinib + chemotherapy (first line) (not_filed), Zipalertinib (pending)
no SEC filing–
Pamela J. Craigdirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
8 or more
ACCENTURE LTD, AKAMAI TECHNOLOGIES INC, VMWARE, INC., WAL MART STORES INC, Merck &amp; Co., Inc., and more
–↗
Risa J Lavizzo-moureydirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
7
AMERADA HESS CORP, GENWORTH FINANCIAL INC, GENERAL ELECTRIC CO, INTEL CORP, Merck &amp; Co., Inc.
–↗
Betty D Larson
EVP, Chief HR Officer
officer
Merck & Co EVP, Chief HR Officer
Source fields<officerTitle>EVP, Chief HR Officer</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
5
BARD C R INC /NJ/, BECTON DICKINSON &amp; CO, GE HealthCare Technologies Inc., Fortrea Holdings Inc., Merck &amp; Co., Inc.
–↗
Patricia F Russodirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
5
ALCOA INC, General Motors Co, HEWLETT PACKARD CO, KKR &amp; Co. L.P., Hewlett Packard Enterprise Co
–↗
Inge G Thulindirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
4
3M CO, TORO CO, CHEVRON CORP, Merck &amp; Co., Inc.
–↗
Robert M Davis
Chairman, CEO & President
director and officer
Merck & Co Director · Chairman, CEO & President
Source fields<officerTitle>Chairman, CEO & President</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
4
BAXTER INTERNATIONAL INC, Merck &amp; Co. Inc., BARD C R INC /NJ/, Duke Energy CORP
–↗
Caroline Litchfield
EVP & CFO
officer
Merck & Co EVP & CFO
Source fields<officerTitle>EVP & CFO</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
3
Merck &amp; Co., Inc., Organon &amp; Co., VERIZON COMMUNICATIONS INC
–↗
Chirfi Guindo
EVP, Access, Policy & Comms
officer
Merck & Co EVP, Access, Policy & Comms
Source fields<officerTitle>EVP, Access, Policy & Comms</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
3
BIOGEN INC., Merck &amp; Co., Inc., Beam Therapeutics Inc.
–↗
Douglas M Baker JRdirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
3
US BANCORP \DE\, TARGET CORP, Merck &amp; Co., Inc.
–↗
Paul Rothmandirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
3
CANCER GENETICS, INC, Merck &amp; Co., Inc., LABORATORY CORP OF AMERICA HOLDINGS
–↗
Stephen Mayodirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
3
Merck &amp; Co., Inc., Sarepta Therapeutics, Inc., Allogene Therapeutics, Inc.
–↗
Thomas H Glocerdirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
3
MERCK &amp; CO INC, Merck &amp; Co. Inc., MORGAN STANLEY
–↗
Dean Y Li
Executive VP & President, MRL
officer
Merck & Co Executive VP & President, MRL
Source fields<officerTitle>Executive VP & President, MRL</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
2
Merck &amp; Co., Inc., RECURSION PHARMACEUTICALS, INC.
–↗
Jennifer Zachary
EVP, General Counsel
officer
Merck & Co EVP, General Counsel
Source fields<officerTitle>EVP, General Counsel</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
2
Merck &amp; Co., Inc., REGENXBIO Inc.
–↗
Kathy J Wardendirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
2
NORTHROP GRUMMAN CORP /DE/, Merck &amp; Co., Inc.
–↗
Mary Ellen Coedirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
2
WHOLE FOODS MARKET INC, Merck &amp; Co., Inc.
–↗
Richard R. DeLuca
EVP&Pres, Merck Animal Heallth
officer
Merck & Co EVP&Pres, Merck Animal Heallth
Source fields<officerTitle>EVP&Pres, Merck Animal Heallth</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
2
WYETH, Merck &amp; Co. Inc.
–↗
Sanat Chattopadhyay
Exe V-P & Pres. MMD
officer
Merck & Co Exe V-P & Pres. MMD
Source fields<officerTitle>Exe V-P & Pres. MMD</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
2
Merck &amp; Co., Inc., ASHLAND INC.
–↗
Surendralal Lanca Karsanbhaidirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
2
EMERSON ELECTRIC CO, Merck &amp; Co., Inc.
–↗
Brian Foard
EVP, Specialty, Pharma, & ID
officer
Merck & Co EVP, Specialty, Pharma, & ID
Source fields<officerTitle>EVP, Specialty, Pharma, & ID</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
Christine E Seidmandirector
Merck & Co Director
Source fields<isDirector>1</isDirector>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
Dalton E. Smart III
SVP Fin. - Global Controller
officer
Merck & Co SVP Fin. - Global Controller
Source fields<officerTitle>SVP Fin. - Global Controller</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
David Michael Williams
EVP,Chief Info&Digital Officer
officer
Merck & Co EVP,Chief Info&Digital Officer
Source fields<officerTitle>EVP,Chief Info&Digital Officer</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
David R. Maraldo
EVP & Pres. MMD
officer
Merck & Co EVP & Pres. MMD
Source fields<officerTitle>EVP & Pres. MMD</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
Gaurav K Gupta
EVP, CIDO
officer
Merck & Co EVP, CIDO
Source fields<officerTitle>EVP, CIDO</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
Johannes Jacobus Oosthuizen
EVP, Oncology & Int?l
officer
Merck & Co EVP, Oncology & Int?l
Source fields<officerTitle>EVP, Oncology & Int?l</officerTitle>
· Ifinatamab deruxtecan (withdrawn)
1
Merck &amp; Co., Inc.
–↗
Bruce Trapnell, MD
principal investigator, Children's Hospital Medical Center, Cinc
researcher
IMPALA-2 · Children's Hospital Medical Center, Cincinnati
no SEC filing–registry ↗
Craig McDonald, MD
principal investigator, University of California, Davis
researcher
HOPE-3 · University of California, Davis
no SEC filing–registry ↗
Jad Adaimi
named on the FDA's letter to the sponsor
regulatory
named on BL 125845 · the FDA letter of 2025-07-07
no SEC filing–
Lara Haddad RPh, RAC
Manager, Global Regulatory Affairs
regulatory
named on NDA 218592 · the FDA letter of 2025-04-25
no SEC filing–
Margaret Kayo, PhD, MBA
named on the FDA's letter to the sponsor
regulatory
named on BL 125842 · the FDA letter of 2025-07-09
no SEC filing–
Mark Awadalla
study director, Capricor Inc.
researcher
HOPE-3 · Capricor Inc.
no SEC filing–registry ↗
Neda Aghajani Memar
Senior Director, Global Regulatory Affairs
regulatory
named on BLA 761463 · the FDA letter of 2025-09-22
no SEC filing–
Rachael Easton, MD, Ph.D.
study director, Cogent Biosciences, Inc.
researcher
APEX · Cogent Biosciences, Inc.
no SEC filing–registry ↗
Zosia Piotrowska, MD
study chair, Massachusetts General Hospital
researcher
REZILIENT1 · Massachusetts General Hospital
no SEC filing–registry ↗
Portfolio exposure

A sum divided by the signed calls and the team

Enter an amount and the table divides it across the portfolio's 17 model positions, in the shares KXCO sealed on 15 October 2026, before the FDA acts on any filing in them. Each share is in proportion to how often filings like it were approved first time on the FDA's record, raised where the company's officers and directors have been through two or more FDA approvals at other companies. The page only multiplies: it keeps nothing you type.

FilingSigned callTeam termShare, Book 2Share, Book 1AmountIf approved / if refusedAgainst a day's average trading
Relutrigine Praxis Precision Medicines, PRAXabove averageyes7.65%7.11%+97% / -50%
BBP-418 BridgeBio, BBIOabove averageyes7.50%7.11%+73% / -50%
Infigratinib BridgeBio, BBIOabove averageyes7.50%7.11%+73% / -50%
Tinlarebant Belite Bio, BLTEabove averageno6.23%7.11%+59% / -50%
Zipalertinib Cullinan, CGEMabove averagenot readable6.23%7.11%+228% / -50%
Deucrictibant IR Pharvaris, PHVSbelow averageyes5.91%5.49%+164% / -50%
INO-3107 Inovio, INObelow averageyes5.91%5.49%approved 30 Oct
Lonvo-z Intellia, NTLAbelow averageyes5.91%5.49%+72% / -50%
Lorundrostat Mineralys, MLYSbelow averageyes5.91%5.49%+332% / -50%
Ozekibart Inhibrx Biosciences, INBXbelow averageyes5.91%5.49%no figure
Ulixacaltamide Praxis Precision Medicines, PRAXbelow averageyes5.91%5.49%+130% / -50%
Bezuclastinib Cogent Bio, COGTabove averageyes5.89%5.89%+123% / -50%
AD109 (Oxnimbi) Apnimed, APMDbelow averageno4.81%5.49%+294% / -50%
Molgramostim Savara, SVRAbelow averageno4.81%5.49%+211% / -50%
Quimilza (imsidolimab) Vanda Pharmaceuticals, VNDAbelow averageno4.81%5.49%+169% / -50%
Bezuclastinib (AdvSM) Cogent Bio, COGTbelow averageyes4.55%4.55%+163% / -50%
Bezuclastinib (NonAdvSM) Cogent Bio, COGTbelow averageyes4.55%4.55%+163% / -50%

Against a day's average trading: the amount for each position divided by the company's average daily traded value, shown as a share of one day below a day and in days above it, average daily volume per FINRA consolidated short interest, settlement 2026-10-15; price per stockanalysis.com 2026-11-10 00:36 UTC. Filings on one company share one price, so their shares add up: the totals by company follow. The books themselves are unchanged.

CompanyIts filings in the booksTotal, Book 2Total, Book 1
BridgeBio BBIOBBP-418, Infigratinib15.00%14.22%
Cogent Bio COGTBezuclastinib, Bezuclastinib (AdvSM), Bezuclastinib (NonAdvSM)15.00%15.00%
Praxis Precision Medicines PRAXRelutrigine, Ulixacaltamide13.56%12.61%
Belite Bio BLTETinlarebant6.23%7.11%
Cullinan CGEMZipalertinib6.23%7.11%
Pharvaris PHVSDeucrictibant IR5.91%5.49%
Inovio INOINO-31075.91%5.49%
Intellia NTLALonvo-z5.91%5.49%
Mineralys MLYSLorundrostat5.91%5.49%
Inhibrx Biosciences INBXOzekibart5.91%5.49%
Apnimed APMDAD109 (Oxnimbi)4.81%5.49%
Savara SVRAMolgramostim4.81%5.49%
Vanda Pharmaceuticals VNDAQuimilza (imsidolimab)4.81%5.49%
How the shares were set. Book 1 weights each filing by the first-cycle approval rate of filings like it in the FDA's register, 2022 to 2026, with the ten largest sponsor groups removed: 83.5% for filings called above average and 64.5% for those called below. No company carries more than 15%. Book 2 multiplies a filing's weight by 1.228 where its team term holds. Of eight terms tested under rules sealed before the test ran, only the team passed: with such a team, applications were approved at the first action 89.6% of the time, against 83.6% without. Lobbying the FDA, regulatory consultants named on FDA letters and the company's depth of approvals carried no measurable weight. The books are scored at each FDA decision, against an equal-weight book and the XBI biotech index, and a loss is published as a gain is.
Scored at each decision. Each book is shown against an equal-weight book of the same positions and against XBI, all from the same entry close and valued at 100 there, at the close of the first trading session after each decision was announced, with every open position marked at that close. A loss is published as a gain is. No significance is claimed on a handful of decisions.
BookDecisionValued at the close ofThe bookEqual weightXBI
Book 1INO-31072026-11-02108.07107.76103.60
Book 2INO-31072026-11-02108.64107.76103.60
The books are published as they were signed: book-ledger.jsonl, with its signatures in book-ledger-attest.json, checked against the portfolio's public key in portfolio-pubkey.json, offline and with nothing asked of KXCO.
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Politics

Lobbying, lobby groups, political committees and government service

For each company in the room, this view lists what public records show: its federal lobbying, the lobby groups it belongs to, its political committee, and the national government service its own directors and officers state. Each item carries its source and the date it was read. The view shows no person's own political donations, and it makes no claim about any FDA decision.

The finding first. Lobbying is not a measure of FDA outcomes: in the room's sealed test, an outside firm lobbying the FDA or HHS for a sponsor, or regulatory counsel named in its filings, showed no measurable link to first-cycle approval once year, application type and the sponsor's earlier approvals were held, rate ratio 0.986, z -0.27 across 542 historical applications.
CompanyLobbying reports, 2024 to 2026Listing the FDAPolitical committeeLobby groupsDirectors and officers stating government service
Eli Lilly and Company14413yes161
Gilead Sciences, Inc.13310yes131
Merck & Co., Inc.1156yes351
Novo Nordisk A/S1156yes, matched by its name91
Otsuka Holdings Co., Ltd.818yes72
AstraZeneca PLC814yes16none stated
Takeda Pharmaceutical Company Limited720yes271
Daiichi Sankyo Company, Limited372none511
Ultragenyx Pharmaceutical Inc.292yes5none stated
BridgeBio Pharma, Inc.255yes43
BioMarin Pharmaceutical Inc.235yes, matched by its name8none stated
Telix Pharmaceuticals Limited134yesnone found1
Praxis Precision Medicines, Inc.100none11
Vanda Pharmaceuticals Inc.100nonenone found1
Capricor Therapeutics, Inc.50none1none stated
Pharvaris N.V.40none2none stated
Savara Inc.30none1none stated
Scholar Rock Holding Corporation22none1none stated
Apnimed, Inc.20nonenone foundnone stated
Mineralys Therapeutics, Inc.none filed under its own namenone1none stated
Cogent Biosciences, Inc.none filed under its own namenone1none stated
Cullinan Therapeutics, Inc.none filed under its own namenone21
Belite Bio, Incnone filed under its own namenonenone foundnone stated
Intellia Therapeutics, Inc.none filed under its own namenone22
Taiho Pharmaceutical Co., Ltd.none filed under its own namenone3none stated
Protagonist Therapeutics, Inc.none filed under its own namenonenone foundnone stated
Inovio Pharmaceuticals, Inc.none filed under its own nameyes, matched by its name2none stated
Inhibrx Biosciences, Inc.none filed under its own namenonenone foundnone stated
Eli Lilly and Company

Outside lobbying firms, 2024 to 2026. Tiber Creek Health Strategies, Inc. (10 reports); Tiber Creek Group (10 reports); Forbes-Tate (10 reports); Tarplin, Downs & Young, LLC (10 reports); BROWNSTEIN HYATT FARBER SCHRECK, LLP (10 reports); VENN STRATEGIES (10 reports); Williams and Jensen, PLLC (10 reports); FEROX STRATEGIES (10 reports); Monument Advocacy (10 reports); Todd Strategy Group (10 reports); The Harple Group LLC (9 reports); DLA Piper LLP (US) (7 reports); GRV STRATEGIES LLC (6 reports); MARSHALL & POPP, LLC (6 reports); CHECKMATE GOVERNMENT RELATIONS (6 reports); B HALL STRATEGIES, LLC (5 reports); The Simmons & Russell Group, LLC (3 reports)

Issues reported most often. health issues (107), Medicare and Medicaid (72), pharmacy (47), trade (45).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 288, executive branch 84.

Political committee. ELI LILLY AND COMPANY POLITICAL ACTION COMMITTEE. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$211,000, to Republican candidates US$328,000; 2026 cycle: to Democratic candidates US$239,000, to Republican candidates US$355,000.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), BioNJ (Bio New Jersey), EuropaBio, European Federation of Pharmaceutical Industries and Associations (EFPIA), HealthCare Institute of New Jersey (HINJ), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers Association (JPMA), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Medicines Australia, National Pharmaceutical Council (NPC), Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization, the Business Roundtable, the National Association of Manufacturers, the U.S. Chamber of Commerce.

Katherine Baicker, Ph.D., director. Government service as the filing states it: Member, confirmed by U.S. Senate (2005 - 2007), Council of Economic Advisers, Executive Office of the President. Council of Economic Advisers, Executive Office of the President –Member, confirmed by U.S. Senate (2005 - 2007) DEF 14A filed 2026-03-20

David A. Ricks, on the board of International Federation of Pharmaceutical Manufacturers & Associations (IFPMA): Director, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) source

David A. Ricks, on the board of Pharmaceutical Research and Manufacturers of America (PhRMA): Director, Pharmaceutical Research and Manufacturers of America (PhRMA) source

David A. Ricks, on the board of The Business Roundtable: Director, The Business Roundtable source

J. Erik Fyrwald, on the board of Council on Competitiveness: Director, Council on Competitiveness (Chair) source

Jon Moeller, on the board of US China Business Counsel: Director, US China Business Counsel source

Jon Moeller, on the board of Alliance to End Plastic Waste: Director (Vice-Chair), Alliance to End Plastic Waste source

Holders of 5% or more. Lilly Endowment Inc. (the Endowment) 9.8%; The Vanguard Group 8.6%; BlackRock, Inc. 6.8%.

The five largest holders reporting on Form 13F, 30-Jun-2026. LILLY ENDOWMENT INC, BlackRock, Inc., VANGUARD CAPITAL MANAGEMENT LLC, PNC Financial Services Group, Inc., STATE STREET CORP.

Gilead Sciences, Inc.

Outside lobbying firms, 2024 to 2026. Tiber Creek Group (10 reports); Forbes-Tate (10 reports); JEFFREY J. KIMBELL & ASSOCIATES, INC. (10 reports); Farragut Partners LLP (10 reports); Tarplin, Downs & Young, LLC (10 reports); Empire Consulting Group (10 reports); Capitol Tax Partners, LLP (10 reports); The Duberstein Group Inc. (10 reports); W Strategies, LLC (10 reports); The McManus Group (10 reports); Todd Strategy Group (10 reports); Miller Strategies, LLC (5 reports); B HALL STRATEGIES, LLC (5 reports); TheGROUP DC, LLC (3 reports)

Issues reported most often. health issues (116), Medicare and Medicaid (68), budget and appropriations (31), taxation (20).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 267, executive branch 76.

Political committee. GILEAD SCIENCES INC HEALTHCARE POLICY PAC. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$196,000, to Republican candidates US$251,500; 2026 cycle: to Democratic candidates US$235,000, to Republican candidates US$235,000.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), Biotechnology Innovation Organization (BIO), California Life Sciences, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), European Federation of Pharmaceutical Industries and Associations (EFPIA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Medicines Australia, National Foreign Trade Council, National Pharmaceutical Council (NPC), Pharmaceutical Research and Manufacturers of America (PhRMA), U.S. Chamber of Commerce.

Harish Manwani, director. Government service as the filing states it: member, Singapore Economic Development Board. member of Singapore Economic Development Board (2013-2019) DEF 14A filed 2026-03-20

Ted W. Love, M.D., formerly on the board of Biotechnology Innovation Organization (BIO): Biotechnology Innovation Organization, a trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the U.S. and in more than 30 other countries ► Chair of Board of Directors (2023-2025) source

Daniel O’Day, on the board of Pharmaceutical Research and Manufacturers of America (PhRMA): Current member of the board of directors of the Pharmaceutical Research and Manufacturers of America (PhRMA) organization and of Georgetown University source

Holders of 5% or more. The Vanguard Group 9.01%; BlackRock, Inc. 8.20%; FMR LLC 5.28%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., VANGUARD CAPITAL MANAGEMENT LLC, FMR LLC, STATE STREET CORP, Capital World Investors.

Merck & Co., Inc.

Outside lobbying firms, 2024 to 2026. Tiber Creek Group (10 reports); Tiber Creek Health Strategies, Inc. (10 reports); Forbes-Tate (10 reports); Williams and Jensen, PLLC (10 reports); Tarplin, Downs & Young, LLC (10 reports); Crossroads Strategies, LLC (10 reports); Avenue Solutions (10 reports); W Strategies, LLC (10 reports); Todd Strategy Group (10 reports); The Nickles Group, LLC (6 reports); BROWNSTEIN HYATT FARBER SCHRECK, LLP (5 reports); B HALL STRATEGIES, LLC (5 reports); Capitol Counsel LLC (4 reports); BALLARD PARTNERS (4 reports); Harbinger Strategies, LLC (3 reports)

Issues reported most often. Medicare and Medicaid (96), health issues (80), taxation (39), trade (30).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 207, executive branch 72.

Political committee. MERCK & CO., INC., EMPLOYEES POLITICAL ACTION COMMITTEE (MERCK PAC). Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$216,500, to Republican candidates US$312,000; 2026 cycle: to Democratic candidates US$152,500, to Republican candidates US$281,500.

Lobby groups it belongs to, as published. Academy of Managed Care Pharmacy, Animal Health Institute, Bio New York, BioNJ (Bio New Jersey), Biocom California, Biotechnology Industry Organization, Business Roundtable, California Life Sciences Association, Chemistry Council of New Jersey, Community Oncology Alliance, Council of the Americas, EuropaBio, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), European Federation of Pharmaceutical Industries and Associations (EFPIA), HealthCare Institute of New Jersey (HINJ), Healthcare Distribution Alliance (HDA), Healthcare Leadership Council, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers Association (JPMA), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Medicines Australia, National Association for Biomedical Research, National Association of Manufacturers, National Health Council (NHC), National Pharmaceutical Council (NPC), New Jersey Civil Justice Institute, Pennsylvania Chamber of Business & Industry, Personalized Medicine Coalition, Pharmaceutical Research and Manufacturers of America (PhRMA), Texas Healthcare & Bioscience Institute, U.S China Business Council, U.S. Chamber of Commerce, U.S. Council for International Business, U.S. Global Leadership Campaign.

Stephen L. Mayo, Ph.D., director. Government service as the filing states it: presidential appointee on the National Science Board, National Science Foundation, National Science Board. Dr. Mayo has also served as a presidential appointee on the National Science Foundation’s National Science Board DEF 14A filed 2026-04-08

Holders of 5% or more. BlackRock, Inc. 8.17%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., VANGUARD CAPITAL MANAGEMENT LLC, STATE STREET CORP, WELLINGTON MANAGEMENT GROUP LLP, VANGUARD PORTFOLIO MANAGEMENT LLC.

Novo Nordisk A/S

Outside lobbying firms, 2024 to 2026. Arnold & Porter Kaye Scholer LLP (19 reports); Tarplin, Downs & Young, LLC (10 reports); Williams and Jensen, PLLC (10 reports); NVG, LLC (10 reports); Todd Strategy Group (10 reports); HOLLAND & KNIGHT LLP (10 reports); Public Strategies Washington, Inc. (8 reports); Avoq, LLC (6 reports); The Nickles Group, LLC (6 reports); CHECKMATE GOVERNMENT RELATIONS (6 reports); The Madison Group (5 reports); BALLARD PARTNERS (5 reports); Avoq, LLC (fra Team Subject Matter, LLC) (2 reports); S-3 Group (2 reports)

Issues reported most often. health issues (101), Medicare and Medicaid (75), budget and appropriations (44), taxation (21).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 265, executive branch 74.

Political committee. NOVO NORDISK INC. PAC (NOVO NORDISK PAC), matched by its name. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$184,000, to Republican candidates US$179,000; 2026 cycle: to Democratic candidates US$119,250, to Republican candidates US$85,000.

Lobby groups it belongs to, as published. BioNJ (Bio New Jersey), European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), European Federation of Pharmaceutical Industries and Associations (EFPIA), HealthCare Institute of New Jersey (HINJ), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers Association (JPMA), Massachusetts Biotechnology Council (MassBio), Medicines Australia, Pharmaceutical Research and Manufacturers of America (PhRMA).

Emil Kongshøj Larsen, officer. Government service as the filing states it: policy adviser, Danish Parliament; European Parliament. Prior to joining Novo Nordisk, Mr Larsen worked as a policy adviser in the Danish and European Parliaments, with a focus on economic policy, healthcare, and tax reforms. 20-F filed 2026-02-04

Emil Kongshøj Larsen, on the board of European Federation of Pharmaceutical Industries and Associations (EFPIA): Member of the board of the European Federation of Pharmaceutical Industries and Associations (EFPIA). source

The five largest holders reporting on Form 13F, 30-Jun-2026. Dodge & Cox, LOOMIS SAYLES & CO L P, FRANKLIN RESOURCES INC, MORGAN STANLEY, BANK OF AMERICA CORP /DE/.

Otsuka Holdings Co., Ltd.

Outside lobbying firms, 2024 to 2026. Reinecke Strategic Solutions, Inc. (11 reports); Thorn Run Partners (10 reports); W Strategies, LLC (10 reports); Todd Strategy Group (10 reports); GOVERNMENT SOLUTIONS LLC (7 reports); JEFFREY J. KIMBELL & ASSOCIATES, INC. (6 reports); THE DASCHLE GROUP (4 reports); DB3, LLC (fka THE DASCHLE GROUP) (4 reports)

Issues reported most often. health issues (65), taxation (28), Medicare and Medicaid (23), budget and appropriations (20).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 73, executive branch 21.

Political committee. PHARMAVITE LLC POLITICAL ACTION COMMITTEE (PHARMAVITE PAC). Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$11,000, to Republican candidates US$8,000; 2026 cycle: to Democratic candidates US$13,000, to Republican candidates US$15,000.

Political committee. OTSUKA AMERICA PHARMACEUTICAL INC. POLITICAL ACTION COMMITTEE (OTSUKA US PAC). Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$67,000, to Republican candidates US$91,000; 2026 cycle: to Democratic candidates US$34,000, to Republican candidates US$81,500.

Lobby groups it belongs to, as published. European Federation of Pharmaceutical Industries and Associations (EFPIA), HealthCare Institute of New Jersey (HINJ), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers Association (JPMA), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Pharmaceutical Research and Manufacturers of America (PhRMA).

Yukio Matsutani, Outside Director and Board Member. Government service, in the company's own words: October 1981 Joined Ministry of Health and Welfare (present day Ministry of Health, Labour and Welfare) August 2005 Director-General, Health Policy Bureau, Ministry of Health, Labour and Welfare Mr. Yukio Matsutani has abundant experience and extensive knowledge in healthcare administration and public health, as well as a high level of expertise in health care as a whole. Notice of the 18th Annual Shareholders Meeting

Tatsuaki Kitachi, Outside Director and Board Member. Government service, in the company's own words: April 2010 Commissioner, Public Interest Corporation Commission, Cabinet Office Notice of the 18th Annual Shareholders Meeting

Holders of 5% or more. Otsuka Group Employee Shareholding Fund 2.24%; The Awa Bank, Ltd. 2.08%; Resona Bank, Limited 1.05%; MEDIPAL HOLDINGS CORPORATION 1.01%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Aristotle Capital Management, LLC, Boston Common Asset Management, LLC, RHUMBLINE ADVISERS, PARADIGM ASSET MANAGEMENT CO LLC, GAMMA Investing LLC.

AstraZeneca PLC

Outside lobbying firms, 2024 to 2026. Tiber Creek Group (10 reports); Forbes-Tate (10 reports); Tarplin, Downs & Young, LLC (10 reports); FEROX STRATEGIES (10 reports); W Strategies, LLC (10 reports); Todd Strategy Group (10 reports); JEFFREY J. KIMBELL & ASSOCIATES, INC. (6 reports); PRIME POLICY GROUP (4 reports); Manatt, Phelps, and Phillips (4 reports)

Issues reported most often. health issues (67), Medicare and Medicaid (64), budget and appropriations (10), copyright, patent and trademark (10).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 197, executive branch 62.

Political committee. ALEXION PHARMACEUTICALS INC. PAC. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$61,000, to Republican candidates US$54,000; 2026 cycle: to Democratic candidates US$57,000, to Republican candidates US$55,000.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), Biotechnology Innovation Organization, California Life Sciences (CLS), formerly California Life Sciences Association (CLSA), EuropaBio, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), European Federation of Pharmaceutical Industries and Associations (EFPIA), HealthCare Institute of New Jersey (HINJ), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers Association (JPMA), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Medicines Australia, National Pharmaceutical Council (NPC), Pharmaceutical Research and Manufacturers of America (PhRMA), Rare Disease Company Coalition, the Association of the British Pharmaceutical Industry.

Ruud Dobber, formerly on the board of European Federation of Pharmaceutical Industries and Associations (EFPIA); Pharmaceutical Research and Manufacturers of America (PhRMA), Asia division: Ruud served as a member of the board and executive committee of the European Federation of Pharmaceutical Industries and Associations and was previously Chairman of the Asia division of Pharmaceutical Research and Manufacturers of America. source

David Fredrickson, formerly on the board of European Federation of Pharmaceutical Industries and Associations Japan (EFPIA Japan); Japan Pharmaceutical Manufacturers Association (JPMA): While in Japan, Dave also served as Vice Chairman of the European Federation of Pharmaceutical Industries and Associations Japan and was a Director of the Japan Pharmaceutical Manufacturers Association. source

Holders of 5% or more. BlackRock, Inc. 6.50%; Investor AB 3.33%; The Capital Group Companies, Inc. 4.97%; Wellington Management Group LLP 4.20%.

The five largest holders reporting on Form 13F, 30-Jun-2026. INVESTOR AB, VANGUARD CAPITAL MANAGEMENT LLC, Capital International Investors, NORGES BANK, Capital World Investors.

Takeda Pharmaceutical Company Limited

Outside lobbying firms, 2024 to 2026. Tiber Creek Group (10 reports); Crossroads Strategies, LLC (10 reports); Todd Strategy Group (10 reports); PORTERFIELD, FETTIG & SEARS, LLC (8 reports); HOLLAND & KNIGHT LLP (8 reports); [individual registrant, not named] (5 reports); B HALL STRATEGIES, LLC (5 reports); Farragut Partners LLP (2 reports); ALPINE GROUP PARTNERS, LLC. (1 report); Avenue Solutions (1 report)

Issues reported most often. health issues (45), Medicare and Medicaid (41), taxation (33), trade (26).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 100, executive branch 27.

Political committee. TAKEDA PHARMACEUTICALS AMERICA INC. POLITICAL ACTION COMMITTEE. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$77,500, to Republican candidates US$114,000; 2026 cycle: to Democratic candidates US$72,500, to Republican candidates US$72,000.

Lobby groups it belongs to, as published. Association of the British Pharmaceutical Industry (ABPI - UK), BIOCOM, California Life Sciences Association (CLSA), Campaign and Alliance for Safe Online Pharmacies (ASOP), Digital Therapeutics Alliance (DTA), EuropaBio, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), European Federation of Pharmaceutical Industries and Associations (EFPIA), Farmaindustria (Spain), Farmindustria (Italy), Global Pharmaceutical Manufacturing Leadership Forum (GPMLF), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Society for Pharmaceutical Engineering (ISPE), Japan Association of Vaccine Industries (JAVI), Japan Blood Products Association, Japan Pharmaceutical Manufacturers Association (JPMA), Kansai Pharmaceutical Industries Association, Les entreprises du médicament (LEEM - France), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Medicines Australia, Parenteral Drug Association (PDA), Pharmaceutical Research and Manufacturers of America (PhRMA), Pharmaceutical Supply Chain Initiative (PSCI), Plasma Protein Therapeutics Association (PPTA), Vaccines Europe, Verband Forschender Arzneimittelhersteller (VFA - Germany).

Kimberly A. Reed, director. Government service as the filing states it: Counsel (House of Representatives); Senior Advisor to Secretaries of the Treasury; Director and Chief Executive Officer of the CDFI Fund; Chairman of the Board of Directors, President, and Chief Executive Officer of the Export-Import Bank, United States House of Representatives; United States Department of the Treasury (Secretaries of the Treasury; Community Development Financial Institutions Fund); Export-Import Bank of the United States. Ms. Reed previously served as Counsel for United States House of Representatives, Senior Advisor to United States Secretaries of the Treasury, Director and Chief Executive Officer of Community Development Financial Institutions Fund, Vice President, Financial Markets Policy Relations of Lehman Brothers, President of International Food Information Council Foundation, and Chairman of the Board of Directors, President, and Chief Executive Officer of Export-Import Bank of the United States. 20-F filed 2026-06-17

Julie Kim, on the board of Pharmaceutical Research and Manufacturers of America (PhRMA): She also serves on the board of the Pharmaceutical Research and Manufacturers of America (PhRMA) and is a member of the Council of Korean Americans. source

John Maraganore, Ph.D., formerly on the board of Biotechnology Innovation Organization (BIO): Chairperson of Biotechnology Innovation Organization. source

Giles Platford, formerly on the board of European Federation of Pharmaceutical Industries and Associations (EFPIA): In 2017, he became President of Europe & Canada, where he also represented Takeda as a board member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). source

Giles Platford, formerly on the board of Plasma Protein Therapeutics Association (PPTA): In 2022, he became President of the Plasma-Derived Therapies Business Unit, where he also represented the company as chair of the global executive board for the Plasma Protein Therapeutics Association. source

Elaine Shannon, on the board of Associated Industries of Massachusetts (AIM): Outside of Takeda, Ms. Shannon is involved in industry and community leadership through her membership in the Parenteral Drug Association (PDA) and her service on the Board of Directors of Associated Industries of Massachusetts (AIM). source

Holders of 5% or more. Sumitomo Mitsui Trust Group, Inc. 5.5%; affiliates of BlackRock, Inc. 8.43%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Capital Research Global Investors, FMR LLC, MORGAN STANLEY, ADAGE CAPITAL PARTNERS GP, L.L.C., GOLDMAN SACHS GROUP INC.

Daiichi Sankyo Company, Limited

Outside lobbying firms, 2024 to 2026. Tiber Creek Group (10 reports); Farragut Partners LLP (10 reports); B HALL STRATEGIES, LLC (5 reports); MARSHALL & POPP, LLC (2 reports)

Issues reported most often. health issues (30), taxation (7), Medicare and Medicaid (7), pharmacy (6).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 75, executive branch 1.

Lobby groups it belongs to, as published. AAM (Association for Accessibile Medicines), ABPI (Association of the British Pharmaceutical Industry), AiFD (Association of Research-Based Pharmaceutical Companies), Alsace BioValley, Apifarma (Portuguese Pharmaceutical Association), Bio Ohio, CAPA (Chinese Association for Pharmaceutical Agents), CAPC (China Association of Pharmaceutical Commerce), CPIA (China Pharmaceutical Industry Association), EFPIA (European Federation of Pharmaceutical Industries and Associations), EMIG (Ethical Medicines Industry Group, trade industry association that represents the interests of life sciences companies in the UK), FPMAJ (The Federation of Pharmaceutical Manufacturers’ Associations of JAPAN), Farmaindustria (Spanish Pharmaceutical Association), Farmindustria (Italian Pharma Industry Association), Federchimica (Italian Chemical Industry Association), HDA (The Healthcare Distribution Alliance), HKAPI (The Hong Kong Association of the Pharmaceutical Industry), HealthCare Institute of New Jersey (HINJ), IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), IHK (International Chamber of Commerce Munich/Upper Bavaria), INTERFARMA (Brazilian Research-based Pharmaceutical Manufacturers Association), IPHA (Irish Pharmaceutical Healthcare Association), IRPMA (International Research-based Pharmaceutical Manufactruers Association), JAVI (Japan Association of Vaccine Industries), JFSMI (Japan Federation of Self-Medication Industries), JSMI (Japan Self-Medication Industry Association), Japan Business Federation, Japan Pharmaceutical Manufacturers Association (JPMA), KJPA (Korea Japanese Phamaceutical Association), KPMBA(Korea Pharmaceutical and Bio-Pharma Manufacturers Association), LEEM (French industry association which represents drug companies operating in France), Massachusetts Biotechnology Council (MassBio), Medicines Australia, Nefarma (Vereniging Innovatieve Geneesmiddelen, Association for innovative medicines in the Netherlands), PReMA (Pharmaceutical Research & Manufacturers Association), Pharmaceutical Research and Manufacturers of America (PhRMA), Pharmig (Association of pharmaceutical industry in Austria), RDPAC（R&D-based Pharmaceutical Association Committee), SICOS Biochimie (Syndicat de l'Industrie Chimique Organique de Synthèse et de la Biochimie), SINDUSFARMA (Trade Union of the Pharmaceutical Products Industry in the State of São Paulo), TIPPA (Taiwan International Pharmacy Advancement Association), TPADA (Taipei Pharmaceutical Agents and Distribution Association), TPMMA (Taiwan Pharmaceutical Marketing & Management Association), The Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, The Pharmaceutical Manufactureres' Association of Tokyo (PMAT), Trade Union of Workers in the Chemical, Pharmaceutical Industries of Osasco, Cotia and region, UIC (Union of French chemical industry), Unindustria (Association of Manufacturers and enterprises of Rome, Frosinone, Latina, Rieti, Viterbo), VCI (Association of chemical industry in Bavaria), VfA - Verband forschender Arzneimittelhersteller (German association of research-based pharmaceutical manufacturers), pharma.be (Belgian Pharmaceutical Trade Association).

Takashi Murata, Outside Audit & Supervisory Board Member. Government service, in the company's own words: Apr. 1984 Entered the National Police Agency (hereinafter "NPA") Aug. 2015 Senior Councilor, Commissioner-General's Secretariat, NPA Jan. 2018 Director-General, Security Bureau, NPA Feb. 2019 Ambassador Extraordinary and Plenipotentiary, Embassy of Japan in the Republic of Finland Jan. 2022 Deputy Chief Cabinet Secretary for Crisis Management Apr. 2024 Retired as Deputy Chief Cabinet Secretary for Crisis Management Takashi Murata has accumulated extensive experience and broad knowledge in public administration through his career as a senior official at the National Police Agency. Convocation Notice of the 21st Ordinary General Shareholders Meeting

Holders of 5% or more. Nippon Life Insurance Company 3.88%; GOVERNMENT OF NORWAY 1.31%; The Shizuoka Bank, Ltd. 1.22%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Madison Asset Management, LLC, RHUMBLINE ADVISERS, GAMMA Investing LLC, Salomon & Ludwin, LLC, First Command Advisory Services, Inc.

Ultragenyx Pharmaceutical Inc.

Outside lobbying firms, 2024 to 2026. Mehlman Consulting, Inc. (8 reports); Aviva Strategies (FKA MGB CONSULTING) (2 reports); Miller Strategies, LLC (2 reports); Forbes-Tate (2 reports); ALPINE GROUP PARTNERS, LLC. (2 reports); MGB CONSULTING (1 report)

Issues reported most often. health issues (25), budget and appropriations (14), Medicare and Medicaid (10), medical research (4).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 9, executive branch 2.

Political committee. ULTRAGENYX PHARMACEUTICAL INC. POLITICAL ACTION COMMITTEE (AKA ULTRAGENYX PAC). Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$12,500, to Republican candidates US$6,500; 2026 cycle: to Democratic candidates US$23,500, to Republican candidates US$20,000.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Life Sciences Pennsylvania, Massachusetts Biotechnology Council (MassBio), Rare Disease Company Coalition.

Michael Narachi, formerly on the board of Biotechnology Innovation Organization (BIO); Pharmaceutical Research and Manufacturers of America (PhRMA): Mr. Narachi previously served on the board of directors of BIO, the Biotechnology Innovation Organization, as a member of the board of directors of PhRMA, the Pharmaceutical Research and Manufacturers of America source

Holders of 5% or more. The Vanguard Group 8.8%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., RTW INVESTMENTS, LP, VANGUARD PORTFOLIO MANAGEMENT LLC, AQR CAPITAL MANAGEMENT LLC, STATE STREET CORP.

BridgeBio Pharma, Inc.

Outside lobbying firms, 2024 to 2026. MARSHALL & POPP, LLC (5 reports); Thorn Run Partners (4 reports); Farragut Partners LLP (4 reports); Todd Strategy Group (1 report)

Issues reported most often. pharmacy (16), health issues (8), Medicare and Medicaid (4).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 53, executive branch 2.

Political committee. BRIDGEBIO PHARMA INC. PAC (BRIDGEBIOPAC). Contributions to candidates, as the FEC records them: 2026 cycle: to Democratic candidates US$4,500, to Republican candidates US$23,500.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), California Life Sciences (CLS), formerly California Life Sciences Association (CLSA), European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Rare Disease Company Coalition.

Frank P. McCormick, Ph.D., F.R.S., D.Sc., director. Government service as the filing states it: led the NCI's Ras Initiative, National Cancer Institute, Ras Initiative at the Frederick National Laboratory for Cancer Research. Since 2013, Dr. McCormick has led the National Cancer Institute’s Ras Initiative at the Frederick National Laboratories for Cancer Research overseeing the national effort to develop therapies against Ras-driven cancers. DEF 14A filed 2026-04-24

Hannah A. Valantine, M.D., director. Government service as the filing states it: Chief Officer for Scientific Workforce Diversity; Senior Investigator, Intramural Research Program, National Institutes of Health; National Heart, Lung, and Blood Institute. From April 2014 to September 2020, Dr. Valantine served as Chief Officer for Scientific Workforce Diversity at the National Institutes of Health, and as a Senior Investigator in the Intramural Research Program at the National Heart, Lung, and Blood Institute. DEF 14A filed 2026-04-24

Charles Homcy, M.D., director. Government service as the filing states it: attending physician, San Francisco Veterans Affairs Hospital. Dr. Homcy was a clinical professor of medicine at the University of California, San Francisco Medical School, and attending physician at the San Francisco Veterans Affairs Hospital from 1997 to 2011. DEF 14A filed 2026-04-24

James C. Momtazee, on the board of The Medical Device Manufacturers Association: Mr. Momtazee serves on the boards of directors of Apollo Therapeutics, Enavate Sciences, GondolaBio, LLC, Hanger, Inc., Kriya Therapeutics, Inc., The Medical Device Manufacturers Association, Elevage Medical Technologies, EMT Holdings, Syneos Health, and Roivant Sciences, Inc. (Nasdaq: ROIV). source

Ali J. Satvat, formerly on the board of Healthcare Private Equity Association: Mr. Satvat previously served as a member of the board of directors of the Healthcare Private Equity Association and has been involved in a number of non-profit organizations. source

Holders of 5% or more. The Vanguard Group 8.42%; KKR Genetic Disorder L.P. 6.78%; BlackRock, Inc. 6.58%; Viking Global Entities 6.05%; Janus Henderson Group plc 5.62%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Jupiter Topco LLC, Kohlberg Kravis Roberts & Co. L.P., FARALLON CAPITAL MANAGEMENT, L.L.C., BlackRock, Inc., VIKING GLOBAL INVESTORS LP.

BioMarin Pharmaceutical Inc.

Outside lobbying firms, 2024 to 2026. BGR Government Affairs (10 reports); LMH STRATEGIC SOLUTIONS (3 reports)

Issues reported most often. health issues (20), Medicare and Medicaid (13), TAR (6), taxation (4).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 60, executive branch 4.

Political committee. BIOMARIN PHARMACEUTICAL INC. POLITICAL ACTION COMMITTEE AKA BIOMARIN PAC, matched by its name. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$102,500, to Republican candidates US$96,000; 2026 cycle: to Democratic candidates US$38,000, to Republican candidates US$55,500.

Lobby groups it belongs to, as published. EuropaBio, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), HealthCare Institute of New Jersey (HINJ), Life Sciences Pennsylvania, Medicines Australia, Pharmaceutical Product Stewardship Work Group (PPSWG), Pharmaceutical Research and Manufacturers of America (PhRMA), Rare Disease Company Coalition.

Ian T. Clark, formerly on the board of Biotechnology Industry Organization (BIO): previously served on the board of directors of GoodRx Holdings, Inc. from July 2024 to March 2026, the board of the Biotechnology Industry Organization source

Mark J. Enyedy, formerly on the board of Biotechnology Innovation Organization (BIO): Mr. Enyedy also served on the boards of Fate Therapeutics, Inc., Keryx Biopharmaceuticals, Inc., the American Cancer Society of Eastern New England, and The Biotechnology Innovation Organization. source

Alexander Hardy, on the board of Pharmaceutical Research and Manufacturers of America (PhRMA): He currently serves on the board of directors for the Pharmaceutical Research and Manufacturers of America (PhRMA). source

Timothy P. Walbert, formerly on the board of Biotechnology Innovation Organization (BIO); PhRMA (written 'Pharmaceutical Research and Manufacturing Association (PhRMA)'); Illinois Biotechnology Innovation Organization (iBIO); World Business Chicago: Mr. Walbert was a previous board member of the Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturing Association (PhRMA), the Illinois Biotechnology Innovation Organization (iBIO) and World Business Chicago. source

Cristin Hubbard, on the board of Biotechnology Innovation Organization (BIO): She currently serves on the Board of Directors of the Biotechnology Innovation Organization (BIO), the world’s largest biotech advocacy organization. source

Holders of 5% or more. The Vanguard Group 9.8%; BlackRock, Inc. 9.1%; PRIMECAP Management Company 8.2%; Dodge & Cox 7.2%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., Dodge & Cox, PRIMECAP MANAGEMENT CO/CA/, VANGUARD CAPITAL MANAGEMENT LLC, VANGUARD PORTFOLIO MANAGEMENT LLC.

Telix Pharmaceuticals Limited

Outside lobbying firms, 2024 to 2026. Hall, Render, Killian, Heath & Lyman, P.C. (8 reports); Liberty Partners Group, LLC (4 reports)

Issues reported most often. Medicare and Medicaid (12), health issues (4), medical research (4).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 19, executive branch 8.

Political committee. TELIX PHARMACEUTICALS US INC GOOD GOVERNMENT FUND. Contributions to candidates, as the FEC records them: 2026 cycle: to Democratic candidates US$0, to Republican candidates US$0.

Marie McDonald, director. Government service as the filing states it: member, Australian Takeovers Panel. She was a member of the Australian Takeovers Panel from 2001 to 2010 20-F filed 2026-02-20

Holders of 5% or more. JPMorgan Chase & Co. 5.21%; State Street Corporation 7.30%; Challenger Limited 5.34%; Gnosis Verwaltungsgesellschaft m.b.H 6.10%.

Praxis Precision Medicines, Inc.

Outside lobbying firms, 2024 to 2026. THE KPM GROUP DC LLC (10 reports)

Issues reported most often. pharmacy (10).

Lobby groups it belongs to, as published. Massachusetts Biotechnology Council (MassBio).

Alex Nemiroff, J.D., officer. Government service as the filing states it: law clerk to a federal judge, United States District Court for the Southern District of Florida. Mr. Nemiroff has experience working in commercial and securities litigation while at Greenberg Traurig LLP, and served as law clerk to the Honorable Paul C. Huck of the United States District Court for the Southern District of Florida. DEF 14A filed 2026-04-30

Holders of 5% or more. Entities affiliated with Janus Henderson Group 9.9%; Entities affiliated with Perceptive Advisors 7.2%; Entities affiliated with Point72 5.5%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Jupiter Topco LLC, FMR LLC, BlackRock, Inc., PERCEPTIVE ADVISORS LLC, BAKER BROS. ADVISORS LP.

Vanda Pharmaceuticals Inc.

Outside lobbying firms, 2024 to 2026. MANATOS & MANATOS (10 reports)

Issues reported most often. pharmacy (10).

Phaedra S. Chrousos, director. Government service as the filing states it: political appointee; Associate Administrator; Founding Commissioner of the Technology Transformation Service, General Services Administration (Technology Transformation Service). Prior to joining the Libra Group, Ms. Chrousos served as a political appointee for the Obama Administration from June 2014 to July 2016 in various roles, including as an Associate Administrator for the General Services Administration and Founding Commissioner of the Technology Transformation Service at the General Services Administration. DEF 14A filed 2026-04-23

Holders of 5% or more. BlackRock, Inc. 7.8%; BlackRock Portfolio Management 5.4%; Renaissance Technologies LLC 6.1%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., STATE STREET CORP, AQR CAPITAL MANAGEMENT LLC, RENAISSANCE TECHNOLOGIES LLC, VANGUARD CAPITAL MANAGEMENT LLC.

Capricor Therapeutics, Inc.

Outside lobbying firms, 2024 to 2026. JEFFREY J. KIMBELL & ASSOCIATES, INC. (5 reports)

Issues reported most often. health issues (5).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 26, executive branch 15.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM).

Holders of 5% or more. Nippon Shinyaku Co., Ltd. 11.9%; Suvretta Capital Management, LLC 6.0%; Tang Capital Management, LLC 5.9%; BlackRock, Inc. 5.1%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., TANG CAPITAL MANAGEMENT LLC, MONTANOVA CAPITAL, LLC, STATE STREET CORP, VANGUARD CAPITAL MANAGEMENT LLC.

Pharvaris N.V.

Outside lobbying firms, 2024 to 2026. ArentFox Schiff LLP (6 reports)

Issues reported most often. Medicare and Medicaid (4), pharmacy (4).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 1, executive branch 0.

Lobby groups it belongs to, as published. European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Massachusetts Biotechnology Council (MassBio).

Holders of 5% or more. General Atlantic PH B.V. 12.32%; FMR LLC 7.96%; Entities affiliated with Foresite Capital 7.33%; Viking Global Opportunities Illiquid Investments Sub-Master LP 5.60%; EQT Life Sciences (Formerly LSP V Coöperatieve U.A.) 5.45%; Entities affiliated with venBio Partners, LLC. 5.44%.

The five largest holders reporting on Form 13F, 30-Jun-2026. FMR LLC, GENERAL ATLANTIC, L.P., Foresite Capital Management IV, LLC, venBio Partners LLC, VIKING GLOBAL INVESTORS LP.

Savara Inc.

Outside lobbying firms, 2024 to 2026. LMH STRATEGIC SOLUTIONS (3 reports)

Issues reported most often. pharmacy (3), health issues (2), Medicare and Medicaid (1).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 5, executive branch 0.

Lobby groups it belongs to, as published. Life Sciences Pennsylvania.

Holders of 5% or more. Entities affiliated with Bain Capital Life Sciences, L.P. 9.99%; Persons and entities affiliated with New Enterprise Associates 11.94%; Persons and entities affiliated with Venrock Healthcare Capital Partners III, LP 9.99%; Persons and entities affiliated with Farallon Capital Management, LLC 6.82%; Persons and entities affiliated with Deerfield Mgmt, L.P. 6.62%; Persons and entities affiliated with TCG Crossover 6.03%; Blackrock, Inc. 5.35%.

The five largest holders reporting on Form 13F, 30-Jun-2026. NEA Management Company, LLC, Bain Capital Life Sciences Investors, LLC, Venrock Adviser, LLC, Nantahala Capital Management, LLC, DEERFIELD MANAGEMENT COMPANY, L.P.

Scholar Rock Holding Corporation

Outside lobbying firms, 2024 to 2026. H.A. Cumber & Company, Inc. (4 reports)

Issues reported most often. medical research (2).

Lobbyists' former government posts, as the reports state them, counted without names. Congress 0, executive branch 2.

Lobby groups it belongs to, as published. Massachusetts Biotechnology Council (MassBio).

Holders of 5% or more. FMR LLC 11.9%; Invus Public Equities, L.P. 9.1%; Entities affiliated with Redmile Group, LLC 8.3%; Samsara BioCapital, L.P. 5.3%; T. Rowe Price Associates, Inc. 5.8%.

The five largest holders reporting on Form 13F, 30-Jun-2026. FMR LLC, Siren, L.L.C., BlackRock, Inc., SAMSARA BIOCAPITAL, LLC, WELLINGTON MANAGEMENT GROUP LLP.

Apnimed, Inc.

Outside lobbying firms, 2024 to 2026. Crossroads Strategies, LLC (2 reports)

Issues reported most often. Medicare and Medicaid (2).

Paul Fonteyne, formerly on the board of Pharmaceutical Research and Manufacturers of America (PhRMA); National Pharmaceutical Council: Pharmaceutical Research and Manufacturers of America, and chaired the National Pharmaceutical Council. source

Holders of 5% or more. Morningside 24.85%; Alpha Wave 25.35%; Shionogi 10.61%; Columbia Fund 15.45%; Tao 6.70%.

Mineralys Therapeutics, Inc.

Lobby groups it belongs to, as published. Life Sciences Pennsylvania.

Holders of 5% or more. Catalys Pacific Fund, LP 9.70%; Entities affiliated with RA Capital Management, L.P. 9.60%; Samsara BioCapital, L.P. 7.12%; FMR LLC 6.09%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Catalys Pacific, LLC, RA CAPITAL MANAGEMENT, L.P., BlackRock, Inc., SAMSARA BIOCAPITAL, LLC, FMR LLC.

Cogent Biosciences, Inc.

Lobby groups it belongs to, as published. Massachusetts Biotechnology Council (MassBio).

Holders of 5% or more. Entities affiliated with FMR LLC 9.70%; Entities affiliated with Fairmount Funds Management LLC 8.50%; The Vanguard Group 6.74%; Entities affiliated with BlackRock, Inc. 6.66%; Entities affiliated with Deerfield Mgmt, L.P. 5.30%.

The five largest holders reporting on Form 13F, 30-Jun-2026. FMR LLC, BlackRock, Inc., VANGUARD PORTFOLIO MANAGEMENT LLC, VANGUARD CAPITAL MANAGEMENT LLC, STATE STREET CORP.

Cullinan Therapeutics, Inc.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), Massachusetts Biotechnology Council (MassBio).

Jacquelyn Sumer, Esq., officer. Government service as the filing states it: law clerk to a federal judge, United States District Court (Washington D.C.). She previously worked at Kaye Scholer, LLP and clerked for the Honorable Gladys Kessler at the United States District Court in Washington D.C. DEF 14A filed 2026-04-28

David Meek, formerly on the board of Pharmaceutical Research & Manufacturers of America (PhRMA); European Federation of Pharmaceutical Industries & Associations (EFPIA): From 2016 to 2020, Mr. Meek served on the boards of Pharmaceutical Research & Manufacturers of America and European Federation of Pharmaceutical Industries & Associations. source

Holders of 5% or more. Lynx1 Capital Management LP 14.59%; UBS Oncology Impact Fund L.P 12.45%; Entities affiliated with BVF, Inc. 9.99%; BlackRock, Inc. 7.06%; The Vanguard Group 5.37%; Kynam Capital Management, LP 5.07%.

The five largest holders reporting on Form 13F, 30-Jun-2026. MPM BIOIMPACT LLC, Lynx1 Capital Management LP, BVF INC/IL, BlackRock, Inc., STATE STREET CORP.

Belite Bio, Inc

Holders of 5% or more. Darwin Global Management, Ltd. 7.6%.

The five largest holders reporting on Form 13F, 30-Jun-2026. Darwin Global Management, Ltd., Paradigm Biocapital Advisors LP, RTW INVESTMENTS, LP, MILLENNIUM MANAGEMENT LLC, MAVERICK CAPITAL LTD.

Intellia Therapeutics, Inc.

Lobby groups it belongs to, as published. Alliance for Regenerative Medicine (ARM), Massachusetts Biotechnology Council (MassBio).

Jesse Goodman, M.D., M.P.H., director. Government service as the filing states it: infectious disease physician, Department of Veterans Affairs medical centre (Washington D.C.); Walter Reed Medical Center; chief scientist, U.S. Food and Drug Administration (FDA); deputy commissioner for science and public health, FDA; director; senior advisor to the FDA commissioner, FDA, Center for Biologics Evaluation and Research. Dr. Goodman also is an infectious disease physician at the Washington D.C. Veterans Affairs and Walter Reed Medical Centers. From 2009 until February 2014, Dr. Goodman served as the chief scientist of the U.S. Food and Drug Administration (“FDA”). Dr. Goodman also served as deputy commissioner for science and public health at the FDA from 2009 through 2012. Prior to that, Dr. Goodman was the director of the FDA’s Center for Biologics Evaluation and Research from 2003 to 2009 and a senior advisor to the FDA commissioner from 1998 through 2000. DEF 14A filed 2026-04-30

John M. Leonard, M.D., director and officer. Government service as the filing states it: postdoctoral fellow, National Institutes of Health (National Institute of Allergy and Infectious Diseases). Dr. Leonard completed his residency in internal medicine at Stanford University School of Medicine, and then completed a postdoctoral fellowship in molecular virology at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. DEF 14A filed 2026-04-30

Frank Verwiel, M.D., formerly on the board of Biotechnology Innovation Organization (BIO): Dr. Verwiel was also a member of the board of directors of the Biotechnology Innovation Organization from February 2013 to April 2014. source

Holders of 5% or more. ARK Investment Management LLC 11.8%; The Vanguard Group 10.8%; BlackRock, Inc. 7.0%; State Street Corp 5.3%.

The five largest holders reporting on Form 13F, 30-Jun-2026. ARK Investment Management LLC, BlackRock, Inc., STATE STREET CORP, VANGUARD PORTFOLIO MANAGEMENT LLC, D. E. Shaw & Co., Inc.

Taiho Pharmaceutical Co., Ltd.

Lobby groups it belongs to, as published. HealthCare Institute of New Jersey (HINJ), Japan Pharmaceutical Manufacturers Association (JPMA), Life Sciences Pennsylvania.

Protagonist Therapeutics, Inc.

Holders of 5% or more. Entities affiliated with BlackRock, Inc. 13.42%; Entities affiliated with Farallon Partners, L.L.C. 9.99%; Entities affiliated with The Vanguard Group 8.47%; Entities affiliated with RTW Investments, L.P. 7.92%; Entities affiliated with State Street Corp. 5.02%.

The five largest holders reporting on Form 13F, 30-Jun-2026. BlackRock, Inc., FARALLON CAPITAL MANAGEMENT, L.L.C., RTW INVESTMENTS, LP, VANGUARD PORTFOLIO MANAGEMENT LLC, WELLINGTON MANAGEMENT GROUP LLP.

Inovio Pharmaceuticals, Inc.

Political committee. INOVIO PHARMACEUTICALS, INC. DNA MEDICINES POLITICAL ACTION COMMITTEE, matched by its name. Contributions to candidates, as the FEC records them: 2024 cycle: to Democratic candidates US$1,000, to Republican candidates US$1,000; 2026 cycle: to Democratic candidates US$0, to Republican candidates US$0.

Lobby groups it belongs to, as published. California Life Sciences (CLS), formerly California Life Sciences Association (CLSA), Life Sciences Pennsylvania.

Holders of 5% or more. FMR, LLC 14.2%; Janus Henderson Group, PLC 9.6%; Alyeska Investment Group, L.P. 5.8%.

The five largest holders reporting on Form 13F, 30-Jun-2026. FMR LLC, Jupiter Topco LLC, VANGUARD CAPITAL MANAGEMENT LLC, Boxer Capital Management, LLC, ADAR1 Capital Management, LLC.

Inhibrx Biosciences, Inc.

Holders of 5% or more. Entities affiliated with Viking Global Opportunities Illiquid Investments Sub-Master LP 10.05%; Entities affiliated with Perceptive Life Sciences Master Fund, Ltd. 9.99%; Inhibrx, Inc. 8.00%; Entities affiliated with Morgan Stanley 7.98%; Entities affiliated with BlackRock, Inc. 5.31%.

The five largest holders reporting on Form 13F, 30-Jun-2026. MORGAN STANLEY, PERCEPTIVE ADVISORS LLC, Sanofi, VIKING GLOBAL INVESTORS LP, HighTower Advisors, LLC.

Shared across the board. Firms and holders that act for three or more of these companies, or law firms acting for two or more.

Lobbying firms. Todd Strategy Group (8); Tiber Creek Group (6); Forbes-Tate (5); Tarplin, Downs & Young, LLC (5); B HALL STRATEGIES, LLC (5); W Strategies, LLC (4); Farragut Partners LLP (4); JEFFREY J. KIMBELL & ASSOCIATES, INC. (4); Williams and Jensen, PLLC (3); Crossroads Strategies, LLC (3); MARSHALL & POPP, LLC (3).

Law firms. Cooley LLP (4); Goodwin Procter LLP (4); Gibson, Dunn & Crutcher LLP (3); HOLLAND & KNIGHT LLP (3); Williams and Jensen, PLLC (3); BROWNSTEIN HYATT FARBER SCHRECK, LLP (2); Davis Polk & Wardwell LLP (2); Finnegan, Henderson Farabow, Garrett & Dunner, LLP (2); Kirkland & Ellis LLP (2); Latham & Watkins LLP (2); Mintz Levin Cohn Ferris Glovsky and Popeo PC (2); Troutman Pepper Hamilton Sanders LLP (2).

Holders. BlackRock, Inc. (19); VANGUARD CAPITAL MANAGEMENT LLC (13); Entities affiliated with State Street Corp. (11); Entities affiliated with The Vanguard Group (9); Entities affiliated with FMR LLC (8); VANGUARD PORTFOLIO MANAGEMENT LLC (6); FARALLON CAPITAL MANAGEMENT, L.L.C. (3); Entities affiliated with Janus Henderson Group (3); Jupiter Topco LLC (3); MILLENNIUM MANAGEMENT LLC (3); Entities affiliated with Morgan Stanley (3); Entities affiliated with RA Capital Management, L.P. (3); Entities affiliated with RTW Investments, L.P. (3); VIKING GLOBAL INVESTORS LP (3); WELLINGTON MANAGEMENT GROUP LLP (3).

How this was read. Lobbying is read from the House Clerk's lobbying disclosures, 2013 onwards: an amended report replaces its original, and a final quarter reported only on a termination counts for its own quarter. Political committees and their contributions to candidates come from the FEC's committee files. Memberships come from the companies' own reports and the groups' published lists. Government service is as each filing states it, read by hand. Gaps: Lilly's political-disclosure page refused our reader; BIO's member list may not be used without its permission, so BIO membership rests on the companies' own words; directors who joined after the latest proxy, and the career histories of some Japanese officers, were not read. Jerini's line runs through Shire to Takeda, and Arcellx is part of Gilead.
Funded to

Funded to, against each company's next FDA decision

12 companies, ranked by the quarters their own cash carries them past their nearest FDA decision, fewest first.

funded after the decisionbalance-sheet date to the decisiona payment duean FDA datean FDA date excluded from the potential-return ranking→beyond 12 quarters

Cash at each company's balance-sheet date per each company's 10-Q or 6-K, with the offerings, loans, preferred sales and payments those reports and later SEC filings state, to 10 November 2026.

quarters after the nearest FDA decision
−4decision4812
1 SVRA Savara
funded to 21 May 2027: cash reaches the 70% of principal ($21.0m) its lender requires from 1 Apr 2027
Molgramostim (MOLBREEVI) 22 Nov 2026 · 2.0 quarters · cash $130m at 30 Sep 2026
spending $42.5m a quarter
If the release holds: 2.5, 5 Jul 2027, while its market value stays above $600m
2 INBX Inhibrx Biosciences
funded to 29 Dec 2027: cash reaches the $40.0m its lender requires
Ozekibart (INBRX-109) 14 Apr 2027 · 2.8 quarters · cash $233m at 30 Jun 2026 with $100.0m drawn 15 Jul 2026 (gross)
spending $29.9m a quarter plus about $2.5m a quarter of interest on the July 2026 loan
due after the funded-to date: the $15.75m final payment on the first two loans and the $9.0m final payment on the July 2026 loan, on 1 Jan 2030
3 VNDA Vanda Pharmaceuticals
funded to 25 Dec 2027: cash runs out
Quimilza (imsidolimab, ANB019) 12 Dec 2026 · 4.1 quarters · cash $140m at 30 Sep 2026
spending $28.4m a quarter
4 NTLA Intellia
funded to 17 Apr 2028: cash reaches the $75m its lender can require
Lonvo-z (NTLA-2002) 10 Mar 2027 · 4.4 quarters · cash $615m at 30 Sep 2026
spending $85.4m a quarter plus about $1.8m a quarter of interest on the September 2026 loan
If the release holds: 4.7, 13 May 2028, if a revenue or market-value test is met
5 PHVS Pharvaris
funded to 6 Aug 2028: cash runs out
Deucrictibant IR (PHA121, PHVS416) 23 Apr 2027 · 5.2 quarters · cash €318m at 30 Jun 2026
spending €37.8m a quarter
6 CAPR Capricor
funded to 20 May 2028: cash runs out
Deramiocel (CAP-1002) 22 Nov 2026 · 6.0 quarters · cash $238m at 30 Jun 2026
spending $31.5m a quarter
7 CGEM Cullinan
funded to 21 Oct 2028: cash runs out
Zipalertinib (CLN-081, TAS6417) 27 Feb 2027 · 6.6 quarters · cash $354m at 30 Jun 2026
spending $38.2m a quarter
8 BBIO BridgeBio
funded to 1 Feb 2029: cash of $411.9m falls short of $747.5m due that day ($747.5m of notes)
BBP-418 (ribitol) 27 Nov 2026 · 8.7 quarters · cash $1,539m at 30 Sep 2026
spending $44.2m a quarter plus $16.3m a quarter of the preferred dividends in cash
later FDA dates: Infigratinib 4 Feb 2027
pays $16.3m of the preferred dividends on 15 Oct 2026; $550.0m of notes on 15 Mar 2027
9 COGT Cogent Bio
funded to 1 Mar 2029: cash runs out
Bezuclastinib (CGT9486) 30 Nov 2026 · 9.0 quarters · cash $791m at 30 Sep 2026
spending $80.8m a quarter plus about $0.9m a quarter of the notes' coupons
later FDA dates: Bezuclastinib (NonAdvSM) 30 Dec 2026, Bezuclastinib (AdvSM) 29 Jun 2027
10 MLYS Mineralys
funded to 12 Oct 2029: cash runs out, after repaying its $100.0m loan by 30 Jun 2028
Lorundrostat 22 Dec 2026 · 11.2 quarters · cash $625m at 30 Sep 2026
spending $43.1m a quarter
pays $25.0m of loan principal on 30 Sep 2027, 31 Dec 2027, 31 Mar 2028 and 30 Jun 2028 if the FDA has not approved lorundrostat by 30 September 2027; a $1.5m final fee on 30 Jun 2028
11 PRAX Praxis Precision Medicines
funded to 5 Sep 2030: cash runs out
Relutrigine (PRAX-562) 27 Dec 2026 · 14.8 quarters · cash $1,286m at 30 Sep 2026
spending $81.7m a quarter
later FDA dates: Ulixacaltamide 29 Jan 2027
12 APMD Apnimed
funded to 31 Dec 2030: cash of $15.1m falls short of $15.3m due that day ($13.8m of loan principal, $0.9m of interest and $0.6m of premium)
AD109 (Oxnimbi) 28 Feb 2027 · 15.4 quarters · cash $373m at 30 Jun 2026 with $200.4m from shares sold on 3 Aug 2026 (net)
spending $18.1m a quarter plus about $1.2m a quarter of interest on its loan once its in-kind election ends, falling as it is repaid
pays $13.8m of loan principal on 30 Sep 2030 unless its 2029 net sales reach $200m; $0.6m of premium on 30 Sep 2030
Not ranked
BLTE Belite Bio, no quarterly figure
BMRN BioMarin, cash generative
Not drawn
ACLX Arcellx, acquired by Gilead, not a single-asset name
NVO Novo Nordisk, not read
Funded to
The first day the company could not keep spending at its last quarter's rate from its own cash. On that day its cash would run out, fall below the cash a lender requires it to hold, or fall short of a payment due, whichever comes first. Each row says which.
Quarters funded after the decision
The time from the nearest FDA target date to the funded-to date, in quarters of 365.25 / 4 days. The rows are ranked on it.
How it is counted
Cash and investments at the balance-sheet date, with the events after it. Spending at the last quarter's operating cash flow comes off evenly by day. Principal, interest the quarter did not pay, coupons, dividends paid in cash and fees each come off on the day they are paid. A convertible note's principal counts as cash at maturity. Cash a lender requires the company to hold is the floor under the balance. Floating rates take SOFR at 3.65%.
Left out
A release that turns on the FDA decision or the share price is not relied on, and the row shows the released case. Payments that depend on sales, approval or a lender's discretion are not counted.
Runway
The room's figure elsewhere: cash and investments divided by the cash the company's operations used in its last reported quarter.
Regulatory standing and upside

Regulatory standing and implied upside

The 19 filings still awaiting an FDA decision, in order of their FDA target date, soonest first, with the days to go in the first column. Standing counts the regulatory concerns recorded against each one, and neither it nor the implied upside to the major banks' median target orders the table. Standing describes the evidence in this dataset. It is not a probability of approval, and a filing with nothing recorded against it can still be refused.

63%of applications clear the first cycle
13of 19 have no concern recorded
6concern recorded
0material concern
12days to the nearest decision, Molgramostim
This table gives no drug a percentage probability of approval. We ranked these filings with a composite score until 23 September 2026 and then withdrew it. Its first backtest failed because the dataset had been researched unevenly. When both groups of drugs were searched under one rule, the score met the backtest's criterion, but its ranking was led by the largest sponsors, because its main term counts how many trials a company runs. A percentage built on the same evidence would repeat that error. This view shows a sourced base rate and dated facts about each filing instead. Check 4 under Methodology and validation gives the full account. The Portfolio exposure view divides a sum in percentages. Those are shares of the sum, in proportion to how often filings like each were approved first time, and they are not chances either.
The base rate, and it is about applications and not about any one of these. In the 2018–2022 cycle of Prescription Drug User Fees, 37% of biologics license applications and new drug applications received a complete response letter. So roughly 63% clear the first cycle, 2018 to 2022 PDUFA cycle. advisory.avalerehealth.com ↗

No concern recorded is not a prediction. 13 of these 19 filings have nothing recorded against them, and the base rate says roughly 37% of applications receive a complete response letter. The base rate describes that historical population, not any filing here, and a missing concern in this dataset is not evidence that a filing carries low risk.
Advisory committee search. An advisory committee meeting is among the most significant scheduled events a filing can face, and the one held for a filing on this board voted 9 to 3 against. All 19 filings awaiting a decision on 2026-11-10 were searched by name against Federal Register notices published since 2025-09-01, and 0 are named in one.

The control. A search that finds nothing must be shown to be able to find something. The identical query was run for deramiocel, whose advisory committee sat on 29 July 2026 and voted 9 to 3 against. It returns the 3 Federal Register notices that convened that meeting. A nonsense name returns nothing. So a nil result here is a meeting that has not been noticed, and not a search that cannot find one.

Not a statement that no meeting will be held. A meeting can be scheduled before it is noticed, and the FDA's own calendar page renders in the browser and cannot be read at source, so it is not used here rather than being read as empty.
Upside and recorded concerns can coincide. carries implied upside, with its standing at . The widest upside on a filing with no concern recorded is at .
The scenario calculation, and which input is an assumption. 
target = p * approval_case + (1 - p) * refusal_case
approval_case = (target - (1 - p) * refusal_case) / p
The calculation treats the banks' median target as a blend of the two outcomes, which is itself an assumption: on that reading the target understates the approval case and hides the refusal case. Splitting it needs four inputs. Three are sourced and one is not, and the one that is not is named.

Price: sourced from stockanalysis.com, stamped to the minute. Target: the median of the major banks' own price targets, each sourced to its rating action.
p at 74.3% for a filing called above average and 60.6% for one called below, the rate the filing's call carries, counted across every application that reached a first FDA action from 1 January 2024 to 31 July 2026, refused ones included, at the low end of its range, as the first screen uses it.
a 50% fall on refusal. an assumption, stated and shown across a band, not a sourced figure.

The result moves with that assumption. At a 30% fall the approval case is smaller, at 70% it is larger, and the refusal case is that fall. A reader who expects a larger fall on refusal should read the right-hand figures as conservative. The reward-to-risk ratios and the timing map inherit every one of these assumptions.
DaysDrugTarget date StandingWhat the dataset holdsBanks' target If approvedIf refused
12Molgramostim
Savara · SVRA · inhaled protein
the company is the drug
2026-11-22
priority review
concern recordeda refuse to filea PDUFA extensionthe FDA declined to convene an advisory committee+108.3%
5.04 to 10.5
+211% to 15.69-50% to 2.52, 4.23x reward to risk
17BBP-418
BridgeBio · BBIO · small molecule
material
2026-11-27
priority review
no concern recordedthe FDA declined to convene an advisory committee+41.1%
77.94 to 110.0
+73% to 134.57-50% to 38.97, 1.45x reward to risk
20Bezuclastinib
Cogent Bio · COGT · small molecule
material
2026-11-30
priority review
no concern recordedthe FDA declined to convene an advisory committee+78.8%
33.55 to 60.0
+123% to 74.95-50% to 16.77, 2.47x reward to risk
32Quimilza (imsidolimab)
Vanda Pharmaceuticals · VNDA · antibody
the company is the drug
2026-12-12
standard review (inferred)
no concern recordednothing recorded either way+82.9%
4.1 to 7.5
+169% to 11.04-50% to 2.05, 3.39x reward to risk
42Lorundrostat
Mineralys · MLYS · small molecule
the company is the drug
2026-12-22
standard review (inferred)
no concern recordednothing recorded either way+181.8%
15.79 to 44.5
+332% to 68.3-50% to 7.89, 6.65x reward to risk
43Anito-cel
Arcellx, acquired by Gilead · ACLX · BCMA CAR-T
not computable
2026-12-23
standard review (inferred)
no concern recordednothing recorded either wayno major-bank targetnot appliedno major-bank target to decompose
47Relutrigine
Praxis Precision Medicines · PRAX · small molecule
material
2026-12-27
priority review
concern recordeda PDUFA extensionthe FDA declined to convene an advisory committee+59.1%
333.09 to 530.0
+97% to 655.72-50% to 166.54, 1.94x reward to risk
50Bezuclastinib (NonAdvSM)
Cogent Bio · COGT · small molecule
material
2026-12-30
standard review (inferred)
no concern recordedthe FDA declined to convene an advisory committee+78.8%
33.55 to 60.0
+163% to 88.1-50% to 16.77, 3.25x reward to risk
Q4CagriSema
Novo Nordisk · NVO · peptide combo
a rounding error
2026-Q4
standard review (inferred)
no concern recordednothing recorded either way-3.4%
41.4 to 40.0
not appliedthe banks' target for a company this size is not set by this filing, so splitting it against this decision would be arithmetic without meaning
80Ulixacaltamide
Praxis Precision Medicines · PRAX · small molecule
material
2027-01-29
standard review (inferred)
no concern recordedthe FDA declined to convene an advisory committee+59.1%
333.09 to 530.0
+130% to 766.31-50% to 166.54, 2.6x reward to risk
86Infigratinib
BridgeBio · BBIO · small molecule
material
2027-02-04
priority review
no concern recordednothing recorded either way+41.1%
77.94 to 110.0
+73% to 134.57-50% to 38.97, 1.45x reward to risk
94Tinlarebant
Belite Bio · BLTE · small molecule
material
2027-02-12
priority review
no concern recordednothing recorded either way+30.9%
157.35 to 206.0
+59% to 250.04-50% to 78.67, 1.18x reward to risk
109Zipalertinib
Cullinan · CGEM · small molecule
material
2027-02-27
standard review (inferred)
concern recordeda safety signal in a trial of the drug+156.4%
11.7 to 30.0
+228% to 38.35-50% to 5.85, 4.56x reward to risk
110AD109 (Oxnimbi)
Apnimed · APMD · oral small molecule combination
the company is the drug
2027-02-28
standard review (inferred)
concern recordedan FDA request for more dataFDA inspection findings, a Form 483+158.7%
15.85 to 41.0
+294% to 62.5-50% to 7.92, 5.89x reward to risk
110Vosoritide (Voxzogo)
BioMarin · BMRN · peptide
material
2027-02-28
standard review (inferred)
no concern recordednothing recorded either way+52.9%
57.23 to 87.5
not appliedour method states no view on this filing
120Lonvo-z
Intellia · NTLA · in vivo CRISPR
the company is the drug
2027-03-10
priority review
concern recordedan FDA request for more datathe FDA declined to convene an advisory committee+24.0%
12.1 to 15.0
+72% to 20.82-50% to 6.05, 1.44x reward to risk
155Ozekibart
Inhibrx Biosciences · INBX · antibody
the company is the drug
2027-04-14
standard review (inferred)
concern recordeda safety signal in a trial of the drugFDA inspection findings, a Form 483no major-bank targetnot appliedno major-bank target to decompose
164Deucrictibant IR
Pharvaris · PHVS · oral small molecule
material
2027-04-23
standard review (inferred)
no concern recordednothing recorded either way+79.6%
34.53 to 62.0
+164% to 91.09-50% to 17.27, 3.28x reward to risk
231Bezuclastinib (AdvSM)
Cogent Bio · COGT · small molecule
material
2027-06-29
standard review (inferred)
no concern recordedthe FDA declined to convene an advisory committee+78.8%
33.55 to 60.0
+163% to 88.1-50% to 16.77, 3.25x reward to risk
Company exposure differs. The same FDA decision matters more to a company with one asset than to a large company with many. The line under each drug gives the decision's weight in its company: "the company is the drug", "material", or "a rounding error", the label the signed portfolio rules use for a decision that is a small part of a large company. Filings labelled "a rounding error" show no approval and refusal figures, because splitting the banks' target for a company the size of Novo Nordisk against one filing would not be meaningful.
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Filing timeline

Regulatory filing timeline

Each row is one filing awaiting an FDA decision. It shows the filing's registered trial milestones, the FDA's actions and the sponsor's announcements on the dates recorded for them, and ends at the FDA target date. The key below explains each mark.

Setback: a complete response letter, a refusal to file, an advisory committee vote against, a safety finding, an FDA information request or FDA inspection findingsProgress: the FDA accepted the filing, or said no advisory committee is plannedOther recorded event, such as a target date extensionA registered trial reaches its primary completion dateFDA target dateTarget given only as a quarterThe date this page was built, 10 November 2026

The line through each row runs from its first recorded event to its target date. Events before January 2025 sit at the left edge, and a trial completion registered only to the month is placed on the 15th. Hover over, tab to or select a mark to read its date and event. Select a filing to open its evidence in the graph.

Jan 2025AprJulOctJan 2026AprJulOctJan 2027AprJul
1 event after July 2027
1 event after July 2027
4 events after July 2027
1 event after July 2027
1 event after July 2027
1 event after July 2027
Built
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Timing and reward to risk

Days to each target date against the scenario reward to risk

The chart places each pending filing by the number of days to its FDA target date, from left to right, and by its scenario reward to risk, from bottom to top. The ratio comes from the split of the major banks’ median target that Regulatory standing and upside sets out, and it holds only under that view's stated assumptions. Select a filing to open its evidence in the graph.

Called above averageCalled below averageA concern is recorded against the filing (standing: concern recorded). It does not change the call.Target within 90 days and a scenario ratio of 3 or moreLarger circles: a larger options straddle to the first expiry on or after the decision. With no options priced, drawn smallest: AD109

A call is KXCO’s prediction, signed before the FDA acts, of whether a filing is more or less likely than the average filing to be approved on its first review: above average with two or three of a drug rather than a biologic, a sponsor that already holds an FDA approval and priority review, below average with one or none. It concerns the FDA’s decision, not the share price. The shaded area only marks where those two thresholds meet. It is not a recommendation. The ratio is a scenario calculation, set out under Regulatory standing and upside, and depends on its stated assumptions. The table under the chart gives each value.

012345670306090120150180210240270300Within 90 days, ratio of 3 or moreMolgramostimBezuclastinib (AdvSM)ZipalertinibLonvo-zDeucrictibant IRUlixacaltamideLorundrostatTinlarebantQuimilzaRelutrigineBezuclastinib (NonAdvSM)BezuclastinibInfigratinibBBP-418AD109Days to the FDA target dateScenario reward to risk
Read the chart as a table
FilingTarget dateCallDays to goScenario ratioOptions straddle
2026-11-22below average124.2389%
2026-11-27above average171.4512%
2026-11-30above average202.4720%
2026-12-12below average323.3937%
2026-12-22below average426.6539%
2026-12-27above average471.9432%
2026-12-30below average503.2524%
2027-01-29below average802.6041%
2027-02-04above average861.4519%
2027-02-12above average941.1837%
2027-02-27above average1094.5653%
2027-02-28below average1105.89not priced
2027-03-10below average1201.4444%
2027-04-23below average1643.2843%
2027-06-29below average2313.2553%
Not placed, and why.
  • : excluded from the ranking
  • : no listed price
  • : a decision window, not a date
  • : our method states no view on this filing
  • : no major-bank target to decompose
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Paired decisions

Achondroplasia: two target dates, 24 days apart

Where two filings on the board treat the same condition, this view sets them side by side: what each sponsor disclosed, the evidence recorded on each, the signed call and its rationale, and the market figures with their sources. The dates are FDA target dates, not decisions already made. Select a drug's name to open its evidence in the graph.

4 February 2027

the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia.
4 February 202728 February 2027

24 days

28 February 2027

BioMarin's supplemental New Drug Application for full approval of VOXZOGO
BridgeBio (BBIO)the sponsorBioMarin (BMRN)
4 February 2027target date28 February 2027
Prioritythe reviewStandard, inferred
Small moleculethe moleculePeptide
PROPEL 3registered trialsNCT03197766
above averagethe callno call
Features recorded at signing: a drug rather than a biologic: yes (investor.bridgebio.com ↗); priority review: yes (investor.bridgebio.com ↗); a sponsor with an approval in the FDA register: yes (api.fda.gov ↗).call rationaleA supplement to an approved drug (sNDA). The profile was measured on original applications, so it says nothing about this filing. No call.
BBIO 65.35price at the callBMRN 57.18
$77.94price now$57.23
+41%upside to the major banks' median target+53%
$15.2bnmarket value$11.1bn
19%options straddle to the first expiry on or after the decision20%

Hereditary angioedema: two target dates, 44 days apart

10 March 2027

the FDA asked the gene editing biotech for additional preclinical data on the inclusion of female patients of child-bearing potential
10 March 202723 April 2027

44 days

23 April 2027

FDA acceptance of New Drug Application for deucrictibant IR
Intellia (NTLA)the sponsorPharvaris (PHVS)
10 March 2027target date23 April 2027
Prioritythe reviewStandard, inferred
In vivo CRISPRthe moleculeOral small molecule
HAELOregistered trialsRAPIDe-3, CHAPTER-4, CREAATE
below averagethe callbelow average
Features recorded at signing: a drug rather than a biologic: no (sec.gov ↗); priority review: yes (ir.intelliatx.com ↗); a sponsor with an approval in the FDA register: no (api.fda.gov ↗).call rationaleFeatures recorded at signing: a drug rather than a biologic: yes (sec.gov ↗); priority review: no (inferred: no sponsor document states priority review, and the goal date falls twelve months after submission, the standard clock. Not stated by the sponsor.); a sponsor with an approval in the FDA register: no (api.fda.gov ↗).
NTLA 12.26price at the callPHVS 31.19
$12.10price now$34.53
+24%upside to the major banks' median target+80%
$1.7bnmarket value$2.4bn
44%options straddle to the first expiry on or after the decision43%
Market data sources. The current prices and the market values are from stockanalysis.com, read 2026-11-10 00:36 UTC; the upside is to the major banks' median price target, each bank sourced to its rating action. The moves priced across the decisions are from Cboe delayed quotes. The price at the call is the one the signed ledger recorded. Hover over or select a figure to see its source and time.
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Market expectations

Market expectations and the regulatory evidence

The rest of this page records what the FDA, the sponsors and the registries have put in writing. This view adds what the market prices: the share price move the options market implies across each decision, the cash each company holds if the FDA refuses, and what each company's directors and officers did with their own shares in the last 90 days. These figures are not KXCO calls. Each one shows its source and the time it was read.

FilingTarget date Options-implied move to the first expiry afterThe decision alone Cash and investmentsNet cash per share Runway at last quarter's spendingInsider trades, 90 days
Deramiocel (CAP-1002)
Capricor
2026-11-22±114.6%
to 2026-11-27, 5 days after the decision
±73.6%$238m
at 2026-06-30
41.5% of the price7.6 quartersno open-market trades
Molgramostim (MOLBREEVI)
Savara
2026-11-22±89.0%
to 2026-12-18, 26 days after the decision
the expiry after the decision is priced no richer than the one before$130m
at 2026-09-30
8.9% of the price
after $30m of debt
3.1 quartersno open-market trades
BBP-418 (ribitol)
BridgeBio
2026-11-27±11.6%
to 2026-12-18, 21 days after the decision
the expiry after the decision is priced no richer than the one before$1,539m
at 2026-09-30
-19.7% of the price
after $3,398m of debt and $1,134m of preferred stock
34.8 quarterssold $5m on a plan
Bezuclastinib (CGT9486)
Cogent Bio
2026-11-30±19.8%
to 2026-12-18, 18 days after the decision
the expiry after the decision is priced no richer than the one before$791m
at 2026-09-30
9.7% of the price
after $224m of debt
9.8 quarterssold $2m on a plan
Quimilza (imsidolimab, ANB019)
Vanda Pharmaceuticals
2026-12-12±36.7%
to 2026-12-18, 6 days after the decision
not isolable$140m
at 2026-09-30
56.6% of the price4.9 quartersbought under $0.1m
Lorundrostat
Mineralys
2026-12-22±38.9%
to 2027-01-15, 24 days after the decision
±21.7%$625m
at 2026-09-30
37.6% of the price
after $98m of debt
14.5 quarterssold $3m outside a 10b5-1 plan; sold $2m on a plan
Anito-cel (CART-ddBCMA)
Arcellx, acquired by Gilead
2026-12-23no US-listed equity quoted for this filingn/anot a single-asset namenot a single-asset namenot a single-asset namen/a
Relutrigine (PRAX-562)
Praxis Precision Medicines
2026-12-27±31.5%
to 2027-01-15, 19 days after the decision
the expiry after the decision is priced no richer than the one before$1,286m
at 2026-09-30
13.8% of the price15.7 quartersno open-market trades
Bezuclastinib (NonAdvSM, CGT9486)
Cogent Bio
2026-12-30±24.1%
to 2027-01-15, 16 days after the decision
the expiry after the decision is priced no richer than the one before$791m
at 2026-09-30
9.7% of the price
after $224m of debt
9.8 quarterssold $2m on a plan
CagriSema
Novo Nordisk
2026-Q4decision dated to a quarter, not a day: no expiry can bracket itn/anot readnot readnot readn/a
Ulixacaltamide (PRAX-944)
Praxis Precision Medicines
2027-01-29±41.3%
to 2027-02-19, 21 days after the decision
±14.6%$1,286m
at 2026-09-30
13.8% of the price15.7 quartersno open-market trades
Infigratinib
BridgeBio
2027-02-04±18.7%
to 2027-02-19, 15 days after the decision
±5.8%$1,539m
at 2026-09-30
-19.7% of the price
after $3,398m of debt and $1,134m of preferred stock
34.8 quarterssold $5m on a plan
Tinlarebant (LBS-008)
Belite Bio
2027-02-12±36.9%
to 2027-03-19, 35 days after the decision
±20.9%$780m
at 2026-06-30, stale: over 120 days old, and it files no 10-Q
12.3% of the priceno quarterly figuresold $32m on a plan
Zipalertinib (CLN-081, TAS6417)
Otsuka (Taiho), with Cullinan, its U.S. co-developer
2027-02-27±53.0%
to 2027-03-19, 20 days after the decision
the expiry after the decision is priced no richer than the one before$354m
at 2026-06-30
46.9% of the price9.3 quarterssold $0.8m on a plan
AD109 (Oxnimbi)
Apnimed
2027-02-28no listed options on APMD, per the Options Clearing Corporationn/a$373m
at 2026-06-30
49.0% of the price
after $50m of debt
20.6 quartersno open-market trades
Vosoritide (Voxzogo)
BioMarin
2027-02-28±20.5%
to 2027-04-16, 47 days after the decision
the first expiry after the decision is 47 days later$666m
at 2026-09-30
-31.6% of the price
after $4,174m of debt
cash generativesold $1m outside a 10b5-1 plan
Lonvo-z (NTLA-2002)
Intellia
2027-03-10±43.8%
to 2027-04-16, 37 days after the decision
the last expiry before the decision is 54 days earlier$615m
at 2026-09-30
31.8% of the price
after $74m of debt
7.2 quarterssold under $0.1m outside a 10b5-1 plan; sold $0.4m on a plan
Ozekibart (INBRX-109)
Inhibrx Biosciences
2027-04-14±50.9%
to 2027-05-21, 37 days after the decision
the last expiry before the decision is 54 days earlier$233m
at 2026-06-30
-3.2% of the price
after $276m of debt
7.8 quartersbought $6m; sold $0.3m outside a 10b5-1 plan
Deucrictibant IR (PHA121, PHVS416)
Pharvaris
2027-04-23±43.0%
to 2027-06-17, 55 days after the decision
the first expiry after the decision is 55 days later€318m
at 2026-06-30, stale: over 120 days old, and it files no 10-Q
in EUR, not per share8.4 quarterssold $16m outside a 10b5-1 plan; sold $5m on a plan; Modig Berndt disposed of $10m, filed as code M
Bezuclastinib (AdvSM, CGT9486)
Cogent Bio
2027-06-29±53.4%
to 2028-01-21, 206 days after the decision
the first expiry after the decision is 206 days later$791m
at 2026-09-30
9.7% of the price
after $224m of debt
9.8 quarterssold $2m on a plan
Options-implied moves. An at-the-money straddle pays out on a move in either direction, so its price as a share of the stock price is the size of move the options market is pricing. It runs to the first expiry after the target date and so includes every ordinary trading day before it. The decision alone is read only where expiries sit within 45 days on both sides of it; elsewhere the column says why it cannot be isolated.
Cash is not a valuation floor. A company that receives a complete response letter can trade below its cash, and operating spending reduces that cash over time. Net cash is after the debt the company reports. Two companies file only annually, outside the United States, and their figures are marked stale rather than converted or estimated.

Share price moves around past FDA announcements

Each return runs from the last close before an announcement to the first close after it, net of the return on XBI, the equal-weight biotech index fund, over the same two sessions. A complete response letter is dated by the day the sponsor announced it, which can differ from the date on the letter. These 12 events are a small historical sample. They describe what happened and do not forecast future moves.

AnnouncedDrugDecision StockXBINet 20 sessions before
2025-04-28Pixclara (floretyrosine F 18)
Telix Pharmaceuticals
refusal letter-7.7%+2.0%-9.7%+7.4%
2025-07-11Deramiocel
Capricor
refusal letter-35.2%-0.1%-35.1%-17.9%
2025-07-11Fayuvi (rebisufligene etisparvovec-hopf)
Ultragenyx
refusal letter-5.8%-0.1%-5.7%-17.3%
2025-09-23Apitegromab (Isembyld)
Scholar Rock
refusal letter+3.5%+0.1%+3.4%-8.2%
2026-04-01Orforglipron (Foundayo)
Eli Lilly, large company
approved+1.7%+1.0%+0.8%-8.7%
2026-05-15Baxdrostat (Baxfendy)
AstraZeneca, large company
approved-0.6%-5.3%+4.8%-7.7%
2026-08-05Oveporexton (Orzeyful)
Takeda, large company
approved+2.8%+1.7%+1.1%-2.4%
2026-08-28Rusfertide (Mimrylo)
Takeda and Protagonist Therapeutics
approved-1.2%-3.4%+2.2%+7.8%
2026-09-11Pixclara (floretyrosine F 18)
Telix Pharmaceuticals
approved-1.0%+0.5%-1.5%-0.6%
2026-09-11Apitegromab (Isembyld)
Scholar Rock
approved-6.9%+0.5%-7.4%+3.4%
2026-09-17Fayuvi (rebisufligene etisparvovec-hopf)
Ultragenyx
approved+12.7%+1.6%+11.0%-49.5%
2026-10-30INO-3107
Inovio
approved+145.5%-3.6%+149.1%-36.4%

The wider calendar companies have disclosed

32 decision dates from 28 companies not on this board, each as the company's own SEC filing states it, found by full-text search on 2026-11-10. None has had the research a board name gets, so none is on the board. A company that announces a date only in a press release it never files with the SEC is not here.

DecisionCompanyTicker The filing that states it
2026-11-14Summit Therapeutics Inc.SMMT8-K filed 2026-11-04
2026-11-14CYTOKINETICS INCCYTK10-Q filed 2026-11-04
2026-11-25SanofiSNY6-K filed 2026-07-30
2026-11-28PolyPid Ltd.PYPD6-K filed 2026-10-28
2026-11-30VERTEX PHARMACEUTICALS INC / MAVRTX10-Q filed 2026-11-03
2026-12-03EXELIXIS, INC.EXEL10-Q filed 2026-10-29
2026-12-17CORCEPT THERAPEUTICS INCCORT8-K filed 2026-11-03
2026-12-27Viatris IncVTRS8-K filed 2026-08-06
2027-01-21Dyne Therapeutics, Inc.DYN8-K filed 2026-11-05
2027-01-28INSMED IncINSM8-K filed 2026-10-29
2027-01-30Pharming Group N.V.PHAR6-K filed 2026-10-27
2027-02-01AGIOS PHARMACEUTICALS, INC.AGIO8-K filed 2026-11-05
2027-02-02GILEAD SCIENCES, INC.GILD10-Q filed 2026-10-30
2027-02-07Verastem, Inc.VSTM8-K filed 2026-11-05
2027-02-18ARGENX SEARGX6-K filed 2026-10-22
2027-02-23Arcutis Biotherapeutics, Inc.ARQT10-Q filed 2026-11-04
2027-02-28PALVELLA THERAPEUTICS, INC.PVLA8-K filed 2026-11-05
2027-02-28Sarepta Therapeutics, Inc.SRPT10-Q filed 2026-11-05
2027-03-03EXELIXIS, INC.EXEL8-K filed 2026-10-29
2027-03-11BRISTOL MYERS SQUIBB COBMY10-Q filed 2026-10-29
2027-03-16Aquestive Therapeutics, Inc.AQST8-K filed 2026-11-05
2027-03-23Aquestive Therapeutics, Inc.AQST8-K filed 2026-11-03
2027-03-29Aquestive Therapeutics, Inc.AQST8-K filed 2026-11-03
2027-04-01Harmony Biosciences Holdings, Inc.HRMY8-K filed 2026-11-04
2027-04-16Jazz Pharmaceuticals plcJAZZ8-K filed 2026-11-02
2027-04-28Immunome Inc.IMNM8-K filed 2026-11-09
2027-05-01uniQure N.V.QURE8-K filed 2026-11-04
2027-05-01Axsome Therapeutics, Inc.AXSM8-K filed 2026-11-02
2027-05-13BRISTOL MYERS SQUIBB COBMY10-Q filed 2026-10-29
2027-05-27Zenas BioPharma, Inc.ZBIO8-K filed 2026-11-05
2027-05-28Eton Pharmaceuticals, Inc.ETON8-K filed 2026-11-05
2027-06-14UroGen Pharma Ltd.URGN8-K filed 2026-11-04
Short interest and fails

The short side of every company on the clock

Who is betting against each company, read three ways. The fee to borrow a stock and the shares a broker can lend move through the trading day. The share of daily volume marked short and the shares that failed to deliver move daily. Short interest, the official count of shares sold short, is published twice a month. None of these figures is a KXCO call, and each one shows its source and the time it was read. The tables are ordered by days to cover.

Through the day: the cost and supply of borrowed shares

Company and filingsFee to borrow, a yearShares Interactive Brokers can lend
Inhibrx Biosciences INBX
Ozekibart
0.30%650,000
Savara SVRA
Molgramostim
0.47%5,700,000
Cogent Bio COGT
Bezuclastinib
0.28%1,600,000
Vanda Pharmaceuticals VNDA
Quimilza
0.28%1,100,000
Cullinan CGEM
Zipalertinib
0.45%1,200,000
BridgeBio BBIO
BBP-418, Infigratinib
0.41%3,000,000
Praxis Precision Medicines PRAX
Relutrigine, Ulixacaltamide
0.43%250,000
Belite Bio BLTE
Tinlarebant
0.54%300,000
Capricor CAPR
Deramiocel
2.03%750,000
Intellia NTLA
Lonvo-z
0.27%2,600,000
Mineralys MLYS
Lorundrostat
0.41%3,200,000
BioMarin BMRN
Vosoritide
0.35%3,100,000
Pharvaris PHVS
Deucrictibant IR
0.55%900,000
Apnimed APMD
AD109
2.96%100,000
Novo Nordisk NVO
CagriSema
0.28%>10000000

Read from the public short-stock file Interactive Brokers publishes at ftp2.interactivebrokers.com, which it refreshes through the day. The figures above are from the file stamped 2026-11-09 19:36:11 US Eastern, read at the room’s last full update; when this view opens, it shows the latest read of the file. It is one broker’s inventory, not the market’s, so a small number means this broker is running short of stock to lend. A rising fee with falling availability means borrowing is getting harder.

Each day: short volume and fails to deliver

Company and filingsOff-exchange volume marked short, 20 sessionsThe last 10 sessionsDays with failsShares failedValue failedLargest single day
Inhibrx Biosciences INBX
Ozekibart
66.6%67.9%632,008$3,526,87031,034
2026-09-15
Savara SVRA
Molgramostim
54.8%48.7%3568,311$2,877,790519,414
2026-09-29
Cogent Bio COGT
Bezuclastinib
55.1%48.4%3114$3,60272
2026-09-25
Vanda Pharmaceuticals VNDA
Quimilza
53.0%50.1%5122,800$631,26479,287
2026-09-29
Cullinan CGEM
Zipalertinib
67.0%62.9%118$26718
2026-09-28
BridgeBio BBIO
BBP-418, Infigratinib
53.0%51.0%15,445$366,5035,445
2026-09-18
Praxis Precision Medicines PRAX
Relutrigine, Ulixacaltamide
58.8%58.8%1135,429$9,011,64726,972
2026-10-14
Belite Bio BLTE
Tinlarebant
67.3%72.1%21,794$280,2301,740
2026-10-07
Capricor CAPR
Deramiocel
51.4%55.7%10218,398$2,011,194158,910
2026-10-01
Intellia NTLA
Lonvo-z
45.5%44.7%6524,188$6,357,099399,250
2026-09-30
Mineralys MLYS
Lorundrostat
28.1%20.3%211,550$288,37610,220
2026-10-01
BioMarin BMRN
Vosoritide
61.0%62.1%663,949$3,851,13738,871
2026-10-05
Pharvaris PHVS
Deucrictibant IR
39.5%33.9%11,009$32,0051,009
2026-10-01
Apnimed APMD
AD109
48.1%47.2%993,101$2,410,64450,733
2026-09-21
Novo Nordisk NVO
CagriSema
39.7%41.0%13177,890$6,977,282121,034
2026-10-08

The short share is read from FINRA’s daily files for 2026-10-13 to 2026-11-09. It is not short interest: market makers mark many routine trades short, so it sits near half for most stocks whatever the price does. A fail to deliver is a sale whose shares were not delivered on the settlement date; the SEC publishes them about four weeks behind, and this table covers settlement dates from 2026-09-15 to 2026-10-14, read from the SEC’s index of fails data.

Twice a month: short interest

Company and filingsShares short, 2026-10-15Change since the last settlementDays to coverShare of all sharesLast 6 settlements
Inhibrx Biosciences INBX
Ozekibart
3,417,073-0.5%16.823.2%
Savara SVRA
Molgramostim
28,737,897-34.0%12.211.3%
Cogent Bio COGT
Bezuclastinib
19,661,566+1.0%8.911.3%
Vanda Pharmaceuticals VNDA
Quimilza
8,309,808+6.1%8.313.7%
Cullinan CGEM
Zipalertinib
7,640,003+0.1%8.211.9%
BridgeBio BBIO
BBP-418, Infigratinib
19,997,556+1.7%7.710.3%
Praxis Precision Medicines PRAX
Relutrigine, Ulixacaltamide
3,921,934-6.4%7.414.0%
Belite Bio BLTE
Tinlarebant
1,267,440+19.9%7.13.1%
Capricor CAPR
Deramiocel
19,860,451+5.5%6.634.2%
Intellia NTLA
Lonvo-z
44,435,219-1.5%6.531.6%
Mineralys MLYS
Lorundrostat
7,438,452-4.7%5.38.4%
BioMarin BMRN
Vosoritide
12,050,657+4.6%4.96.2%
Pharvaris PHVS
Deucrictibant IR
2,465,342+22.8%4.03.5%
Apnimed APMD
AD109
1,803,968+2.2%3.94.3%
Novo Nordisk NVO
CagriSema
37,436,108+18.4%3.1Novo Nordisk's primary listing is Copenhagen; the short interest here is the US ADR line only.

Short interest is the number of shares sold short and not yet bought back, as reported to FINRA for each mid-month and month-end settlement. Days to cover divides it by average daily volume. The share of all shares is KXCO’s own division: FINRA publishes the share count only, so it is divided by market value over price, read for the same US line, and it is left out where the US line is not the whole company.

These figures describe trading in each company’s shares. They are not a view on how the FDA will decide, and they are not a recommendation to buy or sell any security.
Heat map

Every filing on the clock, by days to announcement and how often filings like it cleared their first review

20 filings await an FDA decision; Deramiocel is excluded from the ranking. Select a tile for its brief.

ColourSize
83.5% cleared first review: called above average64.5% cleared first review: called below averageNo signed call, no rate7 days or fewer to the FDA date, or past itExcluded from the ranking
Called above averageCalled below averageNo callExcluded from the ranking
No concern recordedConcern recordedMaterial concernExcluded from the ranking
8 to 30 days 4 filings priced
31 to 90 days 6 filings priced
More than 90 days 7 filings priced
Not sized: no move priced by options 3 filings
  • Anito-cel: no US-listed share is quoted for it.
  • CagriSema: its decision is dated only to a quarter, so no options expiry can bracket it.
  • AD109: there are no listed options on APMD, per the Options Clearing Corporation.
8 to 30 days 4 filings
31 to 90 days 7 filings
More than 90 days 8 filings
A quarter, no day given 1 filing
Call
A call is KXCO’s prediction, signed before the FDA acts, of whether a filing is more or less likely than the average filing to be approved on its first review: above average with two or three of a drug rather than a biologic, a sponsor that already holds an FDA approval and priority review, below average with one or none. It concerns the FDA’s decision, not the share price.
Rate
how often filings like this one were approved at their first review, among the drugs the FDA’s register shows approved, 2022 to 2026, the ten largest sponsor groups removed. Approved drugs only, so each is higher than the rate the first screen uses for the same call. The signed calls are scored on it; the first screen uses the rate across every application, refused ones included.
Groups
days to the FDA’s target date, counted from today; groups as at 10 November 2026; a filing past its date stays red until a decision is recorded.
Size
the move options price across the decision: how far the share price could go, not which way.
Colour
the rate, the standing on the FDA record or our signed call; never a share price.

The map as a table

The same filings, soonest FDA date first. The signed ledger: ledger.jsonl.

no concern recordedconcern recordedmaterial concernexcluded from the ranking● our signed call: above average○ below average◌ no call
FilingFDA dateDays to announcementRateStandingCall · ledger lineMove priced by options
Capricor
2026-11-22in 12 daysexcluded○ 12±114.6%
Savara
2026-11-22in 12 days64.5%○ 4±89.0%
BridgeBio
2026-11-27in 17 days83.5%● 10±11.6%
Cogent Bio
2026-11-30in 20 days83.5%● 5±19.8%
Vanda Pharmaceuticals
2026-12-12in 32 days64.5%○ 17±36.7%
Mineralys
2026-12-22in 42 days64.5%○ 3±38.9%
Arcellx, acquired by Gilead
2026-12-23in 43 days64.5%○ 13no US-listed share is quoted for it
Praxis Precision Medicines
2026-12-27in 47 days83.5%● 21±31.5%
Cogent Bio
2026-12-30in 50 days64.5%○ 14±24.1%
Praxis Precision Medicines
2027-01-29in 80 days64.5%○ 22±41.3%
BridgeBio
2027-02-04in 86 days83.5%● 16±18.7%
Belite Bio
2027-02-12in 94 days83.5%● 8±36.9%
Otsuka (Taiho), with Cullinan, its U.S. co-developer
2027-02-27in 109 days83.5%● 7±53.0%
Apnimed
2027-02-28in 110 days64.5%○ 20there are no listed options on APMD, per the Options Clearing Corporation
BioMarin
2027-02-28in 110 daysno call◌ 2±20.5%
Intellia
2027-03-10in 120 days64.5%○ 9±43.8%
Inhibrx Biosciences
2027-04-14in 155 days64.5%○ 19±50.9%
Pharvaris
2027-04-23in 164 days64.5%○ 11±43.0%
Cogent Bio
2027-06-29in 231 days64.5%○ 15±53.4%
Novo Nordisk
2026-Q4a quarter, no day given83.5%● 6its decision is dated only to a quarter, so no options expiry can bracket it
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Research portfolio

Research calls signed before the FDA acts

Each pending filing is called above or below the average filing, using three features that the FDA's own register shows are associated with first-cycle approval. We signed the calls in a ledger before the FDA acted on any of them, and each call is scored only when the FDA acts. The model positions are hypothetical and are tracked separately from the calls. Two sealed books size the same positions for the Portfolio exposure view: Book 1 by the calls, and Book 2 with the team term as well, both signed and anchored on 15 October 2026 before any decision in them. They are published here in full, with the ledger they were signed in, so anyone can check that none has changed since.

A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
7above average
13below average
1no call
17model positions
1FDA decision since signing

1 of 20 calls decided since signing; the rest have no decision yet.

DecisionFilingCallThe three features, each with its sourceModel positionNow
2026-10-30INO-3107
Inovio		below averagea drug, not a biologic: no (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (stated: the FDA designated the review Standard, per Inovio's 8-K of 29 December 2025. Inovio had requested priority review.)		yes, INO 0.9982, per stockanalysis.com 2026-10-14 02:30 UTCapproved 2026-10-30
2026-11-22Deramiocel
Capricor		below averagea drug, not a biologic: no (capricor.com ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (The original BLA was granted priority review (Capricor 10-Q, 14 Aug 2026). The current clock is a Class 2 resubmission extended three months for a major amendment, to which no review designation applies.)		no: excluded from the board's rankingno decision yet
2026-11-22Molgramostim
Savara		below averagea drug, not a biologic: no (investors.savarapharma.com ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: yes (sec.gov ↗)		yes, SVRA 4.81, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2026-11-27BBP-418
BridgeBio		above averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: yes (api.fda.gov ↗)
priority review: yes (investor.bridgebio.com ↗)		yes, BBIO 67.25, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2026-11-30Bezuclastinib
Cogent Bio		above averagea drug, not a biologic: yes (investors.cogentbio.com ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: yes (drugs.com ↗)		yes, COGT 31.02, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2026-12-12Quimilza (imsidolimab)
Vanda Pharmaceuticals		below averagea drug, not a biologic: no (sec.gov ↗)
sponsor already holds an approval: yes (api.fda.gov ↗)
priority review: no (inferred: Vanda requested priority review, but the goal date falls about twelve months after its December 2025 submission, the standard clock. No document states the class.)		yes, VNDA 4.3, per stockanalysis.com 2026-10-14 02:30 UTCno decision yet
2026-12-22Lorundrostat
Mineralys		below averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, MLYS 23.63, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2026-12-23Anito-cel
Arcellx, acquired by Gilead		below averagea drug, not a biologic: no (sec.gov ↗)
sponsor already holds an approval: yes (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		no: no listed equity for this filingno decision yet
2026-12-27Relutrigine
Praxis Precision Medicines		above averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: yes (sec.gov ↗)		yes, PRAX 243.34, per stockanalysis.com 2026-10-14 02:30 UTCno decision yet
2026-12-30Bezuclastinib (NonAdvSM)
Cogent Bio		below averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, COGT 31.02, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2026-Q4CagriSema
Novo Nordisk		above averagea drug, not a biologic: yes (globenewswire.com ↗)
sponsor already holds an approval: yes (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		no: the room's concentration: a rounding errorno decision yet
2027-01-29Ulixacaltamide
Praxis Precision Medicines		below averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, PRAX 243.34, per stockanalysis.com 2026-10-14 02:30 UTCno decision yet
2027-02-04Infigratinib
BridgeBio		above averagea drug, not a biologic: yes (investor.bridgebio.com ↗)
sponsor already holds an approval: yes (api.fda.gov ↗)
priority review: yes (investor.bridgebio.com ↗)		yes, BBIO 65.35, per stockanalysis.com 2026-10-10 01:53 UTCno decision yet
2027-02-12Tinlarebant
Belite Bio		above averagea drug, not a biologic: yes (investors.belitebio.com ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: yes (investors.belitebio.com ↗)		yes, BLTE 159.56, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2027-02-27Zipalertinib
Cullinan		above averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: yes (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, CGEM 15.51, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2027-02-28AD109 (Oxnimbi)
Apnimed		below averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from Apnimed's statement that the review cycle is targeted at ten months from submission, the standard clock for this kind of NDA. Apnimed does not name the review class.)		yes, APMD 17.83, per stockanalysis.com 2026-10-14 02:30 UTCno decision yet
2027-02-28Vosoritide (Voxzogo)
BioMarin		no callA supplement to an approved drug (sNDA). The profile was measured on original applications, so it says nothing about this filing. No call.no: no call, so no group to score it inno decision yet
2027-03-10Lonvo-z
Intellia		below averagea drug, not a biologic: no (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: yes (ir.intelliatx.com ↗)		yes, NTLA 12.26, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2027-04-14Ozekibart
Inhibrx Biosciences		below averagea drug, not a biologic: no (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, INBX 87.08, per stockanalysis.com 2026-10-14 02:30 UTCno decision yet
2027-04-23Deucrictibant IR
Pharvaris		below averagea drug, not a biologic: yes (sec.gov ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, PHVS 31.19, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
2027-06-29Bezuclastinib (AdvSM)
Cogent Bio		below averagea drug, not a biologic: yes (globenewswire.com ↗)
sponsor already holds an approval: no (api.fda.gov ↗)
priority review: no (inferred from the twelve-month clock, not stated by the sponsor)		yes, COGT 31.02, per stockanalysis.com 2026-10-04 07:38 UTCno decision yet
The original signed rules, unchanged
  • Approved counts as approved, including a narrower label or a safety warning, which is noted.
  • ABOVE average: two or three of a drug rather than a biologic, a sponsor already holding an approval, priority review. BELOW average: none or one. No percentage.
  • Filings called BELOW average will be refused more often than filings called ABOVE average. Counted at every decision; no significance is claimed on a handful.
  • A goal date moved by the FDA: the call carries to the new date.
  • A goal date passed with no action: overdue, unscored until the FDA acts.
  • A model portfolio, not money. One equal-weight position per filing whose sponsor's equity the decision moves (the room's concentration is not 'a rounding error' and the company is listed), entered at the last close before its call is signed and closed at the first close after its decision is announced. A company with several filings holds one position per filing. Reported for the ABOVE group, the BELOW group and XBI.
  • A decision's move runs from the last close before the announcement to the first close after it, so a weekend or after-hours announcement is caught either way.
  • A complete response letter counts as refused.
  • Withdrawn by the sponsor before a decision: void, shown, not scored.
Check it yourself. The whole ledger is published as ledger.jsonl. Each line's hash is the SHA-256 of that line's JSON with its keys sorted, no spaces and the hash itself left out, and each line names the hash of the line before it. The last line's hash is the fingerprint below, and the signature over it verifies against the public key.
21ledger entries committed
2026-10-14 02:45signed, UTC
4abc0fe9a77f29c1ML-DSA-87 key
The fingerprint. 5ca1ae15086367f095eb0b46ac699a5b050efb42151eb0d73aab1445b14976b0

That is the SHA-256 head of the call ledger as it stood when it was signed. Every line of the ledger carries the hash of the line before it, so changing any call changes this fingerprint. Anyone can recompute it from the published ledger and check the signature against the public key below, offline, with nothing asked of KXCO.

Public key: portfolio-pubkey.json. Signed envelope: ledger-attest.json. On-chain anchor: 0x7b207b682aa915c43e07f4a9575a381598956b4625f6214fe2faeff3d1bcc4e6.
Why the calls are above or below average, not percentages. We first tested a probability for each filing, on rules fixed before the test ran. Fitted on the 2022 to 2024 decisions, it did not reliably beat the plain base rate on the 2025 and 2026 decisions, so no probability is published. The three features behind the calls were associated with first-cycle approval in every year and every check. Whether the calls are right on these filings can only be shown as the FDA decides them.
Call scorecard

1 of 20 signed calls decided by the FDA

We signed every entry in the call ledger before the FDA acted on its filing, and recorded the ledger's fingerprint on a blockchain. A call is scored only when the FDA acts. Until then, each row shows the call, the day we signed it, the block that recorded it, the share price that day and the days left.

21ledger entries
20calls, above or below average
1no-call entries
1FDA decision since signing

A no-call entry is a filing the method does not cover, recorded with the reason. Under the rules signed with the calls, a target date the FDA extends carries the call to the new date, a filing past its date with no FDA action stays unscored until the FDA acts, and a filing the sponsor withdraws is void and is not scored (void so far: 0). The approvals already on the FDA board were decided before these calls were signed, so they are a separate group and are not scored here.

FilingCallSignedAnchoredPrice at the callTo goOutcome
Inoviobelow average14 October 2026batch 3
ML-DSA-87		block 528617814 October 2026INO 1.00decidedapproveddue 30 October 2026
Capricorbelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026CAPR 8.9512 daysawaiting the FDAdue 22 November 2026
Savarabelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026SVRA 4.8112 daysawaiting the FDAdue 22 November 2026
BridgeBioabove average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026BBIO 67.2517 daysawaiting the FDAdue 27 November 2026
Cogent Bioabove average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026COGT 31.0220 daysawaiting the FDAdue 30 November 2026
Vanda Pharmaceuticalsbelow average14 October 2026batch 3
ML-DSA-87		block 528617814 October 2026VNDA 4.3032 daysawaiting the FDAdue 12 December 2026
Mineralysbelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026MLYS 23.6342 daysawaiting the FDAdue 22 December 2026
Arcellx, acquired by Gileadbelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026not quoted43 daysawaiting the FDAdue 23 December 2026
Praxis Precision Medicinesabove average14 October 2026batch 3
ML-DSA-87		block 528617814 October 2026PRAX 243.3447 daysawaiting the FDAdue 27 December 2026
Cogent Biobelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026COGT 31.0250 daysawaiting the FDAdue 30 December 2026
Novo Nordiskabove average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026NVO 37.32the quarterawaiting the FDAdue Q4 2026
Praxis Precision Medicinesbelow average14 October 2026batch 3
ML-DSA-87		block 528617814 October 2026PRAX 243.3480 daysawaiting the FDAdue 29 January 2027
BridgeBioabove average10 October 2026batch 2
ML-DSA-87		block 512346010 October 2026BBIO 65.3586 daysawaiting the FDAdue 4 February 2027
Belite Bioabove average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026BLTE 159.5694 daysawaiting the FDAdue 12 February 2027
Cullinanabove average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026CGEM 15.51109 daysawaiting the FDAdue 27 February 2027
Apnimedbelow average14 October 2026batch 3
ML-DSA-87		block 528617814 October 2026APMD 17.83110 daysawaiting the FDAdue 28 February 2027
BioMarinno call5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026BMRN 57.18110 daysawaiting the FDAdue 28 February 2027
Intelliabelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026NTLA 12.26120 daysawaiting the FDAdue 10 March 2027
Inhibrx Biosciencesbelow average14 October 2026batch 3
ML-DSA-87		block 528617814 October 2026INBX 87.08155 daysawaiting the FDAdue 14 April 2027
Pharvarisbelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026PHVS 31.19164 daysawaiting the FDAdue 23 April 2027
Cogent Biobelow average5 October 2026batch 1
ML-DSA-65		block 49901197 October 2026COGT 31.02231 daysawaiting the FDAdue 29 June 2027
The price at the call is the one the signed ledger recorded with it; hover it for the source and the time it was read.

Scored by rules signed before the decisions

The calls are scored as they were signed, each at its group’s rate (83.5% for a filing called above average, 64.5% for one called below), beside always approving (100%) and the cohort base rate (63%). The rules were signed on 20 October 2026 and anchored on chain in block 5,552,023, before the FDA acted on any filing they cover: scoring-ledger.jsonl.

ForecastHits, a forecast above one half read as approvalBrier score (lower is better)
Our signed calls1 of 10.126
Always approve1 of 10.000
The cohort base rate1 of 10.137
At these rates every forecast predicts approval, so the hit counts stay identical until a filing is refused; the Brier score, the average squared gap between a forecast and the outcome, is what tells them apart. Filings decided so far: 1. So far always approving beats our signed calls on the Brier score. A withdrawal or a refusal to file is reported and not scored.
A model portfolio kept for research. It is not an offer, a solicitation or a recommendation to buy or sell any security, and it is not personal advice. The calls are on how the FDA is likely to decide, read from the FDA's own register. The potential return on the first screen combines them with the major banks' targets and each company's cash; it illustrates the room's inputs and is not a forecast of any share price. No money is invested. Past decision-day moves describe a handful of events and predict nothing.
Methodology and validation

Retrospective results, corrections and research limitations

Every filing on the board is placed in a regulatory standing tier from its dated regulatory events, and readers rank filings by it, so the tier works as a call. This view tests that call against the 9 filings on the board whose decision is now known, recalculating each one from only the evidence dated before its own decision, because scoring a filing with its outcome already known would describe it rather than test it. All 9 of those decisions were approvals, so this cohort cannot show whether the tiers separate approvals from refusals. The view also records the corrections we have made and the checks on our own evidence.

6 of 9right
3wrong
9 of 9approval-only baseline
0refusals in this sample
Selection limits the result. Every settled outcome in this sample is an approval and none is a refusal, so the sample cannot show whether a call distinguishes an approval from a refusal. A baseline that predicts approval for every filing is right on all of them by construction. That is a property of the sample, not of the FDA.

The wider population. Across BLAs and NDAs generally, 37% received a complete response letter in the 2018 to 2022 PDUFA cycle, per https://advisory.avalerehealth.com/insights/what-is-a-complete-response-letter read 2026-09-23. About 63% therefore clear the first cycle, and a baseline that predicts approval for every filing would be wrong about one time in three. Nothing here suggests that a refusal is rare.
DrugDecidedStanding call OutcomeVerdict What the dataset held before the decision
Icatibant (Firazyr)
Jerini, acquired by Shire
2011-08-25no material concernapprovedrightnothing recorded
Orforglipron (Foundayo)
Eli Lilly
2026-04-01no material concernapprovedrightnothing recorded
Baxdrostat (Baxfendy)
AstraZeneca
2026-05-15no material concernapprovedrightnothing recorded
Oveporexton (Orzeyful)
Takeda
2026-08-05no material concernapprovedrightnothing recorded
Rusfertide (Mimrylo)
Takeda and Protagonist Therapeutics
2026-08-28no material concernapprovedrightnothing recorded
Apitegromab (Isembyld)
Scholar Rock
2026-09-11material concernapprovedwrongcrl 2025-09-22
Pixclara (floretyrosine F 18)
Telix Pharmaceuticals
2026-09-11material concernapprovedwrongcrl 2025-04-25
Fayuvi (rebisufligene etisparvovec-hopf)
Ultragenyx
2026-09-17material concernapprovedwrongcrl 2025-07-07
INO-3107
Inovio
2026-10-30no material concernapprovedrightinfo_request 2025-12-29
Performance against the baseline. The standing call matched 6 of the 9 outcomes. A baseline that predicts approval for every filing matched 9. On this sample the call did worse than that baseline, and the comparison with the baseline matters more than the accuracy figure alone. Among the filings decided in the current cycle, the call matched 5 of 8 and the baseline 8 of 8.
One error behind every miss. All 3 misses have one cause: the rule treated a complete response letter as decisive. Each of those drugs had received a letter, was placed in the material-concern tier because of it, and was later approved.
Board-selection bias. 9 of the 9 decided filings were approved. A screen of filings awaiting a decision does not accumulate refusals: a refused drug leaves the board, while an approved drug is recorded as an outcome. The approval rate inside this sample is therefore far above the rate for applications generally, which is about 63% clearing the first cycle over the 2018 to 2022 PDUFA cycle, per advisory.avalerehealth.com read on 2026-09-23. Every accuracy figure here inherits that bias.

9 decisions are too few to estimate a rate, and none of these figures is one. They count what the rule would have called, and they are published because that count was asked for, whether or not it favours the rule.
What the ones that clear have in common

Recorded features and first-cycle approval

Applications that are refused and then abandoned cannot be observed in public data, so this analysis compares applications that were eventually approved. Whether a drug is ever approved cannot be measured from the FDA's letter library, because the library labels its letters by when they were published, as the withdrawn signal below shows. Whether an application cleared the first cycle is fixed on the day a letter is issued, so both groups can be observed. 451 applications in the window, 77.4% of them clearing first time. Corrected on 15 October 2026: an earlier version of this analysis counted 77 applications in the window twice and counted some sponsors under more than one name. Each application now counts once, and each sponsor's names are matched.

87.1%all three, n=62
55.6%a biologic from a first-time sponsor, n=27
3.28z between the two ends, against an adjusted threshold of 2.92
5 of 5years biologics clear less often
ProfileApplications Cleared the first cycle
every application45177.4%
not a biologic32381.1%
sponsor has prior approvals31480.9%
priority review14683.6%
not a biologic + sponsor has prior approvals21385.4%
not a biologic + priority review9886.7%
sponsor has prior approvals + priority review10183.2%
not a biologic + sponsor has prior approvals + priority review6287.1%
Combined features. Each feature adds to the others and none cancels another. The table shows all 8 combinations rather than the best one, because selecting the best of 8 would overstate the result. Because 8 combinations were examined, the gap between the two ends must exceed z = 2.92 to count, and it is 3.28. This is a retrospective association. It does not establish a cause, or a probability for any one filing.

A possible mechanism. The complete response letters on this board that turned on manufacturing and a third-party facility inspection all concerned biologics. The FDA wrote in one of them that the deficiencies may not be specific to the application.
Time-period sensitivity. Before 2018 the FDA published almost no letters, so an application approved then appears to have cleared the first cycle whatever happened. Biologics were also approved later on average than small molecules, with a mean approval year of 2014.8 against 2006.3, so a comparison across the whole register would confuse product type with period. Across the whole register the difference was z = -6.27, and holding the year constant gives +2.75. The comparison is therefore restricted to the years in which the corpus holds letters, which reduces this bias but does not remove every selection effect.
Incomplete letter coverage. The measured first-cycle rate is 77.4%. The sourced rate for BLAs and NDAs generally is 63%, because 37% receive a complete response letter, per https://advisory.avalerehealth.com/insights/what-is-a-complete-response-letter read 2026-09-23. The difference suggests that some letters issued are not in the published corpus, and the applications that received them are counted here as having cleared. The two populations also differ, so the difference does not measure how many letters are missing. Missing letters dilute each gap between groups towards zero, so each gap should be read as a lower bound.

Drugs@FDA lists approved products, so an application that was refused and then abandoned appears in neither group. The comparison is between applications that cleared the first cycle and those that needed a second, among drugs that were eventually approved.

This is not a probability for any one filing, and not a claim that a biologic is a worse drug. It describes how often each kind of application cleared at the first attempt in this window. The association does not establish a cause, although the complete response letters on this board that turned on manufacturing and facility inspection all concerned biologics.
Withdrawn the same day

A withdrawn signal: the letters' publication dates, not their outcomes

On 23 September we published a rule that appeared to predict which applications would be approved after a complete response letter more accurately than a baseline that assumes all of them would be. We had tested it on the FDA's published letter library. A fuller check a few hours later showed that the result reflected when each letter was published, and we withdrew the rule. This section describes the rule and why it failed. The original figures are kept below as a record of the correction. They are not current evidence.

99.3%of letters up to 2023 read as approved
0.0%of letters from 2025 on do
2024.5mean year of the flagged letters
2020.7mean year of everything else
Publication can encode the outcome. The FDA publishes two different sets in one dataset: batches from its archive, which it says are associated with withdrawn and approved applications and are therefore resolved, and letters as it issues them, which have not yet resolved. So 99.3% of letters dated up to 2023 read as approved and 0% of those dated 2025 or later do. The field encodes roughly when the letter was written.

What the signal was measuring. The flagged letters average 2024.5 and 91% are dated 2024 or later, against 2020.7 and 34% for everything else. Within 2024 alone, holding the year constant, the signal flags one letter of sixty-nine, which leaves nothing to measure.
What this corpus cannot estimate. The corpus cannot give an outcome rate, because publication is conditioned on the outcome. Drugs@FDA cannot supply the missing negatives. It is a register of approved products and it records a drug that was refused and resubmitted as one approved submission, with no trace of the refusal. The two cannot be combined. The corpus holds roughly 50 letters a year against several thousand approvals, so the negative arm is a small and non-random slice.

No public, machine-readable source holds FDA filings with both outcomes at scale, so a refusal predictor cannot be built reliably from public data, and none is published here.

The analysis that follows was exploratory and has been withdrawn. It is kept as a record of the correction. The 9 decided filings on the board could not test a signal, because all 9 were approved and any false alarm would leave a rule behind the baseline. The signals were therefore tested on 457 of the FDA's published complete response letters, each recording the FDA's grounds and whether the application was later approved. On that corpus the baseline, which assumes every application is later approved, is right on 309 of 457, or 67.6%.

Candidate signal, and why it was testedFlagged Of those, later approvedAll other letters GapzAgainst the baseline
the letter cites a failed primary endpoint
The trial missed what it was designed to show.
2740.7%69.3%+28.63.08
clears the 7 test bar
+5
clinical grounds AND a new trial demanded
The grounds say what is wrong and the remedy says how expensive it is.
2147.6%68.6%+21.02.00
does not clear it
+1
the letter raises clinical or statistical grounds
The evidence itself did not carry, rather than the paperwork around it.
4854.2%69.2%+15.02.10
does not clear it
-4
the letter demands a new clinical trial
A new trial is years and money, and the FDA's own reason for publishing these letters is that sponsors often do not disclose when it asks for one.
7676.3%65.9%-10.4-1.78
does not clear it
-40
the letter raises a facility inspection
The agency's own words in one of these are that the deficiencies may not be specific to the application.
23664.4%71.0%+6.61.51
does not clear it
-68
a second or later letter on the same application
The first response did not satisfy the agency.
20174.6%62.1%-12.5-2.84
clears the 7 test bar
-99
the letter turns on safety
A refusal about harm rather than about evidence.
38267.3%69.3%+2.10.35
does not clear it
-132
The withdrawn endpoint result. Narrowed to the phrase that carries the mechanism, the FDA wrote that the study failed to demonstrate efficacy, or did not meet its primary endpoint: 11 letters say it and 9.1% of those came back, against 69.1% of every other refusal, z = 4.2. That result was withdrawn when publication timing and selection were found to compromise the comparison, and the figures are kept only as a record of the correction.

Three versions of the phrase. Against the baseline, the pre-registered phrasing scored 5, the narrowed phrasing, written after seeing the first result, scored 9, and a broader phrasing that counts any mention of failure scored -4. All three belong to the withdrawn analysis.
Two signals ran the other way. A second letter on the same application, and a letter demanding a new trial, were both associated with the application being approved more often, not less. The likely reason is the library rather than the drugs: a sponsor that is still filing after a second letter has not given up, and a programme that is abandoned leaves one letter and no outcome to publish. These are exploratory observations about this corpus, not validated predictors.
Multiple comparisons. Seven candidate signals were tested, so the best of them cannot be reported at the usual threshold. Correcting for seven tests sets the threshold at p below 0.0071. Two results met it: the failed-endpoint signal, and the second-letter effect, which ran in the opposite direction to the one expected. The clinical-grounds split did not, and is reported as suggestive. A statistical threshold does not correct the publication bias described above, and all of these results belong to the withdrawn analysis.
Accuracy and the baseline. Accuracy is a weak test when 68% of cases share one outcome, per https://api.fda.gov/transparency/crl.json read 2026-09-23. A signal can shift the probability substantially and still lose a yes-or-no call, because flagging a case that usually comes back costs more than it saves. The separation between the two groups is the more informative figure, although within this selected corpus it cannot establish prospective probabilities or support position sizing.
The current standing rule. A filing is placed in the material-concern tier only where the FDA wrote that the study failed to demonstrate efficacy or did not meet its primary endpoint, or where an advisory committee voted against it. Every other filing, including one that received a complete response letter on other grounds, is not. On the 9 decided filings it matches 9 of 9, equal to the baseline's 9, and 8 of 8 on the filings decided in the current cycle, against 8 for the baseline. It was written after those outcomes were known, so it needs to be evaluated on future decisions. It is the rule used under Regulatory standing and upside. The rule was first supported by 457 of the FDA's published complete response letters, and that evidence has been withdrawn: the corpus labels a letter as approved or not according to whether the FDA had resolved the case before publishing it, so the measured rate reflected the date of the letter. What remains in support of the rule is the grounds the FDA states in each letter, a mechanism that can be stated in one sentence, and the 9 outcomes it was fitted on. That is a judgement, not a result.

Four of the 457 letters are the four on this board, so applying the rule back to this board is not fully out of sample. The FDA chooses which letters to publish, so the corpus's 67.6% approval rate describes the library rather than refusals in general.
The earlier rule, kept for the correction record. A complete response letter is classified by the grounds the FDA states in it. Clinical or statistical grounds, or an advisory committee vote against, keep a filing in the material-concern tier. A letter that raises only manufacturing or a third-party facility inspection places it in the concern-recorded tier, because the FDA wrote in one of these letters that the deficiencies may not be specific to the application. On the same filings that rule would have matched 8 of 9. This rule was written after these 9 outcomes were known and was scored on the same 9, so the result reflects hindsight and is not evidence. Independent support comes from the FDA's own library, where 309 of 458 published complete response letters relate to applications that were later approved. The test of the rule is the 19 filings still awaiting a decision, and it cannot be run until the FDA decides them. Pixclara received a letter on clinical grounds, which this rule still treats as a concern, and it was approved 17 months later. A refusal on efficacy grounds is not necessarily final either.
Prospective evaluation. A rule written after the outcomes it was fitted on can only be tested on decisions that have not yet been made. These 19 filings each carry a dated standing under Regulatory standing and upside, and each result will be published as the FDA decides.
Evidence-quality checks

Five checks of whether the dataset is sourced and current, run on 2026-11-10 00:51 UTC

These are data-quality checks, not a test of any call. They test the conditions on which everything above depends: if a quoted sentence no longer appears on the page it cites, the claims built on it cannot be relied on. We make three claims about the dataset: every figure is sourced, the sentence behind each figure is on the page it cites, and the dataset is updated when events change it. The results are published as they came out.

Check 1: quotations

Whether each source still contains the sentence quoted from it

Every distinct source and quote pair was re-fetched and searched for the exact sentence, except the claims read from SEC ownership filings: 22 of those were checked on a seeded sample, and the 279 not sampled are left out of every figure here rather than counted as holding. A failure here would invalidate the claims that depend on the quote.

100.0%of reachable quotes still hold
39found in the page body
2found in page metadata only
61could not be re-fetched
193 pairs tested, covering 226 claims. 132 were reachable. Of those, 132 were found word for word: 91 in the registry's, the SEC's or the FDA's own text, read through its own interface, 39 in the body of a web page and 2 only in a page's own metadata, which is weaker evidence because a reader clicking through does not see it. 0 survived substantially. 0 were only partly present and 0 were not found at all. The 61 that could not be re-fetched are recorded as unreachable and never as failures: a bot wall and an absent sentence are different results, and one of the sources here answers with a 126 byte shell that is not a page at all.
Eight quotation errors, corrected. Two quotes had been recorded spliced, two fragments of a page joined with an ellipsis so they read as one sentence. Neither could be found on its own page because neither had ever been on it in that form. Both were replaced with the unjoined sentence, and the record validator now refuses any quote containing an ellipsis. On 12 October six more were found shortened or reworded from their pages, and each was re-cut from the page's own sentence. The same day the test itself was corrected: it now decodes every character a page encodes, so a quote with a "<" sign in it is no longer missed. The failures below are what remains.
VerdictThe quote, and what the page says now Source
Check 2: changes over time

Changes during the historical review window

This check uses dates the dataset was not built on, and each one is recorded. The 2 September record held 8 assets on the FDA clock. By the 22 September refresh, 2 of them had already been decided without the record knowing, and 3 more had dates that firmed or corrected.

25.0%decided before the dataset recorded it
62.5%moved in some way
20days in the window
Pixclara, UX111the two that resolved
A quarter of a live regulatory board went out of date in 20 days. This is a dated maintenance observation, not a general rate of change, and it is why every date here shows whether it was re-read or carried forward, and when.
Check 3: outcomes since the first snapshot

Outcomes since the first snapshot, and the evidence held before them

2 decisions were made between the first snapshot and this review. The recorded signal matched 1 and missed 1. With only 2 decisions, the result is not evidence of skill in either direction, and we do not present it as such.

DrugOutcomeSignal What the dataset held beforehand
Pixclara
decided 2026-09-11
approvedsignal righton the clock, and this record then held no adverse event against it
A record with no concern preceded an approval, so the signal was right. It was right on evidence that was incomplete. On 23 September 2026 the FDA's own letter library showed Pixclara had been refused on 25 April 2025 for want of substantial evidence of effectiveness. This record did not hold that refusal, which is the only reason no concern was recorded against it. The answer was correct and the basis for it was not, and those are different things.
Fayuvi (UX111)
decided 2026-09-17
approvedsignal wrongon the clock, carrying a complete response letter from July 2025
The adverse signal pointed the wrong way, and by a wide margin: the drug received standard full approval, a higher standard than the accelerated pathway it first sought, two days early. This case is the reason the scoring formula is published with its failed test rather than quietly reweighted.
Check 4: the composite score, withdrawn on 2026-09-23

The composite score, and why it was withdrawn

trials + 2*precedent + 2*closed_loop - 2*adverse

In the formula, trials counts registered phase 3 studies, precedent counts approved drugs that serve as a regulatory precedent, closed_loop counts earlier programme links between a person and such a precedent, and adverse counts adverse regulatory or safety events.

We published this composite score together with a backtest that it failed. The first explanation we gave for the failure was wrong. The real cause was uneven research in the dataset. Once that was corrected the score met the backtest's criterion, but its ranking measured the size of each sponsor, so meeting the criterion did not show that the score could predict FDA decisions.

1 of 8approved drugs had a trial on file
9 of 12pending drugs did
0.08 of 1.45of the gap was the term we blamed
3.67 and 2.00trials per drug now, both cohorts
What we first published. We first reported that the composite score failed its backtest because adverse events were charged against a drug and never credited back after it recovered.

What was actually true. That explanation was wrong. The failure came from uneven research in the dataset, not from the design of the score. Only one of the eight approved drugs had a registrational trial recorded, against nine of the twelve pending drugs, because the dataset began as a screen of live filings and the approved drugs were entered only as outcomes. Of the 1.45 point gap between the two groups, trials accounted for 0.71, precedent for 0.33, earlier programme relationships for 0.33 and the adverse events term for 0.08.
Why correcting the research did not save the score. We then searched both groups for trials under one rule. The approved group's mean score became +3.38 and the pending group's +3.08, so the score now met the backtest's criterion. The ranking it produced, however, was led by CagriSema, with 22 registered phase 3 studies at the time, and Orforglipron, with 18. The trials term counts studies, and the largest sponsors can afford to run the most, so the score was mainly measuring the size of the sponsor. Meeting the criterion therefore did not show that the score could predict FDA decisions, and we withdrew it.
What replaces it. No composite score replaces it. The FDA board is ordered by regulatory standing, which is read from dated FDA and sponsor events that each carry a source, and then by the implied upside to the major banks' median target. Each drug still shows the old score's components, because each one is a counted fact. The signed calls in the research portfolio are a separate method: each call places one filing above or below the average filing, and each was signed before the FDA's decision.
Check 5: after a complete response letter

What happened after a complete response letter

The FDA's published letter library makes this check possible. The table lists every filing on this board whose complete response letter is published, and what happened to it afterwards, as the dataset holds it.

3 of 4approved after being refused
4letters read at source
2were missing from the dataset until 23 September
17months, the longest from a letter to approval
DrugLetterWhat happened What the letter raised
Pixclara (floretyrosine F 18)
NDA 218592
2025-04-25approved 2026-09-11chemistry, manufacturing and controls, clinical / statistical
Fayuvi (rebisufligene etisparvovec-hopf)
BL 125845
2025-07-07approved 2026-09-17chemistry, manufacturing and controls, facility inspection
Deramiocel
BL 125842
2025-07-09excludedchemistry, manufacturing and controls, clinical / statistical
Apitegromab (Isembyld)
BLA 761463
2025-09-22approved 2026-09-11chemistry, manufacturing and controls, facility inspection
3 of the 4 filings on this board whose FDA letter is published went on to be approved, so in these cases a complete response letter was not the final decision. The one that has not been approved is the one where the letter says the registrational trial failed its primary endpoint, and an advisory committee later voted against it 9 to 3.
And what it does not show. Four cases is not a sample and this is not a recovery rate. Nor is it clean evidence that a manufacturing refusal can be survived while an efficacy refusal cannot, because Pixclara was refused for want of substantial evidence of effectiveness and was approved 17 months later. The useful thing here is the letters themselves, not a statistic drawn from four of them.
This check found a fault in check 3. The outcomes check above scored Pixclara as having no concern recorded before an approval, and counted the signal as right. The signal was right, but on incomplete evidence: the dataset did not then hold the complete response letter Pixclara had received in April 2025. The case note above now says so.
Research-quality conclusions. All 132 quotations that could be re-checked were found as recorded. The 61 that could not be re-fetched remain unverified, and are counted as unreachable rather than as holding. The board changed by about a quarter in three weeks of the historical window. The outcome sample is too small to support a conclusion, and one of its two cases rested on incomplete evidence. The composite ranking was withdrawn. The check of outcomes after a complete response letter is consistent with approval following a letter on this board, but four cases are not a sample. These limitations are published alongside the evidence they qualify.
Evidence

Evidence sheets

Each drug and company has a sheet that states what the record shows, in words, with every line linked to its source. It opens on the next FDA decision. See the graph shows the same drug or company as a graph of its links. Elsewhere on this page a drug or company name opens its sheet, and any other name opens the graph.

Evidence

Knowledge graph

The record's drugs, companies, trials and events, with each company's people and political links, and the links between them, each with its source. It opens on the next FDA decision. Select a thing to see what it is linked to and the statement behind each link.

Entity directory

Every entity in the dataset

The dataset holds 501 entities of 8 kinds: drugs, companies, regulators, manufacturing sites, trials, conditions, regulatory events and people. Each heading is one kind. Claims: the claims each entity appears in. ↗ opens it in the graph.

EntityDetailClaimsGraph
Public company · 28
ApnimedAPMD1
Arcellx, acquired by GileadACLX1
AstraZenecaAZN2
Belite BioBLTE10
BioMarinBMRN25
BridgeBioBBIO18
CapricorCAPR13
Cogent BioCOGT15
CullinanCGEM17
Daiichi SankyoTSE:45681
Eli LillyLLY19
Inhibrx BiosciencesINBX1
InovioINO1
IntelliaNTLA16
Jerini, acquired by Shireprivate1
Merck & CoMRK27
MineralysMLYS13
Novo NordiskNVO1
Otsuka (Taiho)TSE:45782
PharvarisPHVS14
Praxis Precision MedicinesPRAX2
SavaraSVRA25
Scholar RockSRRK16
TakedaTAK32
Takeda and Protagonist TherapeuticsPTGX9
Telix PharmaceuticalsTLX11
UltragenyxRARE16
Vanda PharmaceuticalsVNDA1
Drug candidate · 32
AD109 (Oxnimbi)PDUFA 2027-02-28 · pending · standard review (inferred)8
Anito-celPDUFA 2026-12-23 · pending · standard review (inferred)6
Apitegromab (Isembyld)approved · priority review6
BBP-418PDUFA 2026-11-27 · pending · priority review5
Baxdrostat (Baxfendy)approved · priority review11
BezuclastinibPDUFA 2026-11-30 · pending · priority review6
Bezuclastinib (AdvSM)PDUFA 2027-06-29 · pending · standard review (inferred)6
Bezuclastinib (NonAdvSM)PDUFA 2026-12-30 · pending · standard review (inferred)6
CagriSemaPDUFA 2026-Q4 · pending · standard review (inferred)14
DeramiocelPDUFA 2026-11-22 · excluded · standard review9
Deucrictibant IRPDUFA 2027-04-23 · pending · standard review (inferred)8
Deucrictibant XRnot_filed4
Fayuvi (rebisufligene etisparvovec-hopf)PDUFA 2026-09-19 · approved · priority review6
INO-3107PDUFA 2026-10-30 · approved · standard review8
Icatibant (Firazyr)approved14
Ifinatamab deruxtecanPDUFA 2026-10-10 · withdrawn · rtor review10
InfigratinibPDUFA 2027-02-04 · pending · priority review5
Lonvo-zPDUFA 2027-03-10 · pending · priority review7
LorundrostatPDUFA 2026-12-22 · pending · standard review (inferred)7
MolgramostimPDUFA 2026-11-22 · pending · priority review10
Orforglipron (Foundayo)approved · standard review18
Oveporexton (Orzeyful)approved · priority review7
OzekibartPDUFA 2027-04-14 · pending · standard review (inferred)7
Pixclara (floretyrosine F 18)approved · priority review5
Quimilza (imsidolimab)PDUFA 2026-12-12 · pending · standard review (inferred)5
RelutriginePDUFA 2026-12-27 · pending · priority review7
Rusfertide (Mimrylo)approved · priority review5
TinlarebantPDUFA 2027-02-12 · pending · priority review6
UlixacaltamidePDUFA 2027-01-29 · pending · standard review (inferred)6
Vosoritide (Voxzogo)PDUFA 2027-02-28 · pending · standard review (inferred)7
ZipalertinibPDUFA 2027-02-27 · pending · standard review (inferred)9
Zipalertinib + chemotherapy (first line)not_filed1
Regulatory event · 54
AD109 NDA accepted2026-07-14 · acceptance1
Accelerated approval on the PDUFA date2026-10-30 · approval1
AdvSM NDA accepted2026-09-15 · acceptance1
Advisory committee voted 9 to 3 against2026-07-29 · adcom_against1
Approved2026-04-01 · approval1
Approved2026-08-05 · approval1
Approved2026-08-28 · approval1
Approved2026-09-11 · approval1
Approved2026-05-15 · approval1
Approved2011-08-25 · approval1
Approved on the PDUFA date2026-09-11 · approval1
BLA accepted2026-02-20 · acceptance1
BLA accepted, priority review2026-09-08 · acceptance1
BLA voluntarily withdrawn after discussions with the FDA2026-09-25 · withdrawal1
Complete response letter2025-07-09 · crl2
Complete response letter2025-07-07 · crl2
Complete response letter2025-09-22 · crl2
Complete response letter2025-04-25 · crl2
Day 74 letter: no advisory committee planned2026-03-06 · adcom_declined1
FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation2026-07-20 · inspection_4831
FDA identified no review issues, no AdCom2026-05-28 · adcom_declined1
FDA identified no review issues, no AdCom2026-03-16 · adcom_declined1
FDA identified no review issues, no AdCom2026-09-15 · adcom_declined1
FDA inspection findings (Form 483), disclosed 13 Aug 20262026-08-13 · inspection_4831
FDA inspection findings at the contract manufacturer (Form 483, September 2025); resolved, per Apnimed's 10-Q of 8 September 20262026-02-17 · inspection_4831
FDA not planning advisory committee2026-09-01 · adcom_declined1
FDA not planning advisory committee2026-05-27 · adcom_declined1
FDA not planning advisory committee2025-12-29 · adcom_declined1
FDA not planning advisory committee2026-08-06 · adcom_declined1
FDA not planning advisory committee2026-04-14 · adcom_declined1
FDA questioned eligibility for accelerated approval2025-12-29 · info_request1
FDA questions on the NDA's adequacy and requests for more data2026-07-14 · info_request1
FDA request for preclinical fetal data2023-08-01 · info_request1
GIST NDA accepted, priority review2026-05-28 · acceptance1
INO-3107 BLA accepted, standard review2025-12-29 · acceptance1
Infigratinib NDA accepted, Priority Review2026-10-06 · acceptance1
NDA accepted2026-07-06 · acceptance1
NDA accepted2026-03-06 · acceptance1
NDA accepted, priority review2026-08-11 · acceptance1
NonAdvSM NDA accepted2026-03-16 · acceptance1
Ozekibart BLA accepted2026-06-15 · acceptance1
PDUFA extended 3 months, major amendment2026-04-15 · extension1
PDUFA extended 3 months, major amendment2026-06-29 · extension1
PDUFA extended, indication narrowed2026-08-24 · extension1
Partial clinical hold after a fatal liver injury, in place by 6 Mar 2023, lifted April 20232023-03-06 · safety_signal1
Pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses2025-11-10 · inspection_4831
Priority review granted, RTOR and Project Orbis2026-04-13 · acceptance1
Quimilza BLA accepted2026-02-25 · acceptance1
REZILIENT3 reported 3 deaths from septic shock2026-09-15 · safety_signal1
Refuse to File, insufficient CMC2025-05-27 · rtf1
Relutrigine NDA accepted, priority review2026-04-06 · acceptance1
Standard full approval, 2 days before the PDUFA date2026-09-17 · approval1
Ulixacaltamide NDA accepted2026-04-14 · acceptance1
sNDA for full approval accepted2026-07-13 · acceptance1
Indication · 25
Achondroplasia2
Advanced systemic mastocytosis1
Autoimmune PAP1
Conventional chondrosarcoma1
Duchenne muscular dystrophy1
EGFR ex20ins NSCLC1
Essential tremor1
Extensive-stage SCLC, 2L1
GIST and systemic mastocytosis1
Generalised pustular psoriasis1
Hereditary angioedema4
LGMD2I/R91
Narcolepsy1
Nonadvanced systemic mastocytosis1
Obesity2
Obstructive sleep apnoea1
Polycythemia vera1
Recurrent or progressive glioma imaging1
Recurrent respiratory papillomatosis1
Relapsed or refractory multiple myeloma, 4L1
Resistant hypertension2
SCN2A and SCN8A developmental and epileptic encephalopathies1
Sanfilippo syndrome Type A (MPS IIIA)1
Spinal muscular atrophy1
Stargardt disease type 11
Person · 280
Adam Scott LevyCFO and Secretary · officer1
Adrienne S BrownEVP, President LLY Imm · officer1
Agosti Marcello PignagnoliHead, Strat. &amp; Port. Dev · officer1
Akshay VaishnawPresident of R&amp;D · director and officer1
Alexander HardyChief Executive Officer · director and officer1
Alexander M Golddirector · director1
Ali Behbahaniten percent owner · ten percent owner1
Ali J. Satvatdirector · director1
Amrit Raydirector · director1
Anat HakimEVP, GC &amp; Secretary · officer1
Andrea Ellisdirector · director1
Andrew Lodirector · director1
Andrew R Allendirector · director1
Andrew R RobbinsPresident and CEO · director and officer1
Andrew Stewart PlumpPresident, R&amp;D · director and officer1
Anna NijdamPrincipal Accounting Officer · officer1
Anne EricksonChief Business Officer · officer1
Anne LesageChief Early Development · officer1
Anne-Marie Martindirector · director1
Anthony A. Florence Jr.ten percent owner · ten percent owner1
Anthony BergmannCHIEF FINANCIAL OFFICER · officer1
Anthony Rosenbergdirector · director1
Arlene Morrisdirector · director1
Arturo Molina MDChief Medical Officer · officer1
Asif AliChief Financial Officer · officer1
Asuka MiyabashiraPresident, Japan Pharma B.U. · officer1
Athena Countouriotisdirector · director1
Awny Samaan Botros FarajallahChief Medical Officer · officer1
Barbara W. Bodemdirector · director1
Berndt ModigCEO, Pharvaris2
Berndt ModigChief Executive Officer · director and officer1
Betty D LarsonEVP, Chief HR Officer · officer1
Birgit C SchultesEVP, Chief Scientific Officer · officer1
Braden C. ParkerChief Commercial Officer · officer1
Brian FoardEVP, Specialty, Pharma, &amp; ID · officer1
Brian Goffdirector · director1
Brian MuellerEVP, Chief Financial Officer · officer1
Brian Taylor Slingsbydirector · director1
Bruce D Broussarddirector · director1
Bruce Trapnell, MDprincipal investigator, Children's Hospital Medical Center, Cincinnati · researcher1
Bryan Giraudodirector · director1
Carmen Changten percent owner · ten percent owner1
Caroline LitchfieldEVP &amp; CFO · officer1
Caryn ParlavecchioCHRO · officer1
Charles Greg GuyerEVP, Chief Technical Officer · officer1
Charles J Homcydirector · director1
Chirfi GuindoEVP, Access, Policy &amp; Comms · officer1
Christian BehrenbruchMD &amp; Group CEO · director and officer1
Christine E Seidmandirector · director1
Christophe Pierre WeberPresident and CEO · director and officer1
Christopher W. Caindirector · director1
Cole PinnowChief Commercial Officer · officer1
Corazon (Corsee) D. Sandersdirector · director1
Corrine SavillChief Business Officer · officer1
Craig McDonald, MDprincipal investigator, University of California, Davis · researcher1
Cristin HubbardEVP, Chief Commercial Officer · officer1
Dalton E. Smart IIISVP Fin. - Global Controller · officer1
Daniel G Welchdirector · director1
Daniel SkovronskyEVP, CS&amp;PO &amp; Pres. LRL · officer1
Daphne Karydasdirector · director1
Darren Charlton SmithGroup Chief Financial Officer · officer1
Darren Joel PattiGroup Chief Operating Officer · officer1
David A Ramsaydirector · director1
David A RicksPresident, Chair, and CEO · director and officer1
David B Musketdirector · director1
David D. Meekdirector · director1
David E I Pyottdirector · director1
David HallalChief Executive Officer · director and officer1
David L LowranceChief Financial Officer · officer1
David LebwohlEVP, Chief Medical Officer · officer1
David Malcom RodmanChief Medical Officer · officer1
David Michael WilliamsEVP,Chief Info&amp;Digital Officer · officer1
David N Gilldirector · director1
David Norman CadeGroup Chief Medical Officer · officer1
David P. Ryandirector · director1
David R. MaraldoEVP &amp; Pres. MMD · officer1
David W. NassifCFO / CLO · officer1
Dean Y LiExecutive VP &amp; President, MRL · officer1
Deborah Dunsiredirector · director1
Dennis Karl HuangSee Remarks · officer1
Derek DiRoccodirector · director1
Dinesh V PH D PatelPresident and CEO · director and officer1
Diogo RauEVP &amp; CIDO · officer1
Donald A ZakrowskiSVP, Finance, &amp; CAO · officer1
Douglas A. Dachilledirector · director1
Douglas M Baker JRdirector · director1
Earl M Collier JRdirector · director1
Edgardo HernandezEVP &amp; Pres., Mfg. Operations · officer1
Edward J Dulac IIIEVP, Chief Financial Officer · officer1
Edward T Mathersten percent owner · ten percent owner1
Elaine J Herondirector · director1
Elaine Mary ShannonPres., Global Supply &amp; Quality · officer1
Eliana ClarkEVP, Chief Technical Officer · officer1
Elisabeth Bjorkdirector · director1
Elizabeth M Andersondirector · director1
Emiko Higashidirector · director1
Emil D KakkisPresident &amp; CEO · director and officer1
Eric Aguiardirector · director1
Eric CrombezEVP and Chief Medical Officer · officer1
Eric DozierEVP, Chief People Officer · officer1
Eric WarrenChief Commercial Officer · officer1
Erik HarrisEVP &amp; Chief Commercial Officer · officer1
Erin BurkhartGVP, Chief Accounting Officer · officer1
Es-Johansson An vandirector · director1
Evan KearnsChief Legal Officer · officer1
Forest Baskettten percent owner · ten percent owner1
Frank Litvackdirector · director1
Frank Mccormickdirector · director1
Frank Verwieldirector · director1
Fred E Cohendirector · director1
Fred Hassandirector · director1
Gabriele RicciChief Data &amp; Tech. Officer · officer1
Gabrielle Sulzbergerdirector · director1
Gary Clark Biddledirector · director1
Gaurav K GuptaEVP, CIDO · officer1
George Eric DavisEVP, Chief Legal Officer · officer1
George W Dunbar JRdirector · director1
Georgia Kerestydirector · director1
Giles Richard PlatfordPresident, IBU · officer1
Glenn Sblendoriodirector · director1
Gregory R FribergEVP, Chief R&amp;D Officer · officer1
Hannah Valantinedirector · director1
Hao-Yuan ChuangChief Financial Officer · director and officer1
Harold E Selickdirector · director1
Hendrik Peter SchollChief Medical Officer · officer1
Henry J FuchsPresident, Worldwide R&amp;D · officer1
Howard HornChief Financial Officer · officer1
Ian T Clarkdirector · director2
Ilya YuffaEVP&amp;Pres, LLY USA&amp;Global Capab · officer1
Inge G Thulindirector · director1
Ita Ludirector · director1
J Erik Fyrwalddirector · director1
Jacquelyn L SumerChief Legal Officer · officer1
Jad Adaiminamed on the FDA's letter to the sponsor · regulatory1
James BastaEVP, General Counsel · officer1
James C Momtazeedirector · director1
James J. Ferguson IIIChief Medical Officer · officer1
Jann Elizabeth Skinnerdirector · director1
Jean Luc Buteldirector · director1
Jeffrey Alan JonesChief Medical Officer · officer1
Jeffrey S. Flierdirector · director1
Jennifer E. Cookdirector · director1
Jennifer Marie SmoterChief Comm. &amp; Gov. Officer · officer1
Jennifer MichaelsonChief Scientific Officer · officer1
Jennifer ZacharyEVP, General Counsel · officer1
Jesse Goodmandirector · director1
Jessica SachsChief Medical Officer · officer1
Jing L. MarantzCHIEF MEDICAL OFFICER · officer1
Jochen KnolleCo-founder and strategic advisor, Pharvaris; CSO and COO to end 20232
Johannes Gerardus Christiaan Petrus Schikandirector · director1
Johannes Jacobus OosthuizenEVP, Oncology &amp; Int?l · officer1
John Edward RobinsonChief Scientific Officer · officer1
John L. GreenChief Financial Officer · officer1
John LeonardCEO, Intellia1
John M LeonardPresident and CEO · director and officer1
John Maraganoredirector · director1
John Michael Longodirector · director1
John Richard PinionSee Remarks · officer1
Jon CongletonCEO, Mineralys1
Jon CongletonChief Executive Officer · director and officer1
Joseph S McCrackendirector · director1
Joshua Reeddirector · director1
Juan R Lucianodirector · director1
Julie So-Young KimPresident and CEO · director and officer1
Junlin HoGENERAL COUNSEL · officer1
Karah Herdman ParschauerEVP and Chief Legal Officer · officer1
Karen Jean Ferrantedirector · director1
Karen KrasneyEVP, GENERAL COUNSEL · officer1
Karimah Es Sabardirector · director1
Kathleen R. McCabeChief Legal Officer · officer1
Kathy J Wardendirector · director1
Katie Pengdirector · director1
Keith WoodsChief Operating Officer · officer1
Kenneth L. CusterEVP &amp; President, Card Met Hlth · officer1
Kimberly A. Reeddirector · director1
Koichiro Kimuradirector · director1
Koji Hatsukawadirector · director1
Kristina Burowdirector · director1
Lara Haddad RPh, RACManager, Global Regulatory Affairs · regulatory1
Lauren Rusckowski DupreyChief Transformation Officer · officer1
Lewis T Williamsdirector · director1
Linda MarbanCHIEF EXECUTIVE OFFICER · director and officer1
Lucas MontarceEVP &amp; CFO · officer1
Mani SharmaSee Remarks · officer1
Margaret Kayo, PhD, MBAnamed on the FDA's letter to the sponsor · regulatory1
Maria Rivasdirector · director1
Maricel ApuliChief Accounting Officer · officer1
Marie Elizabeth McDonalddirector · director1
Mark Alexander Nelsondirector · director1
Mark Awadallastudy director, Capricor Inc. · researcher1
Mark J Enyedydirector · director1
Mary Ellen Coedirector · director1
Mary Kay FentonChief Financial Officer · officer1
Mary Thistledirector · director1
Masami Iijimadirector · director1
Matt PaulsCEO, Savara1
Matthew K Fustdirector · director1
Matthew PaulsCHIEF EXECUTIVE OFFICER · director and officer1
Matthew Rosdirector · director1
Maykin Hodirector · director1
Melissa SeymourEVP, Global Quality · officer1
Michael Gilmandirector · director1
Michael Narachidirector · director1
Michael P DubeVP, Chief Accounting Officer · officer1
Michael T MaurerCHIEF COMMERCIAL OFFICER · officer1
Michel Bruno Orsingerdirector · director1
Mike Kelliherdirector · director1
Miki Tsusakadirector · director1
Milano FurutaChief Financial Officer · director and officer1
Mittie Doyledirector · director1
Mo QatananiCHIEF SCIENTIFIC OFFICER · officer1
Mohamad Makhzoumiten percent owner · ten percent owner1
Muna Bhanjidirector · director1
Naarden Jacob VanEVP,Pres LLY Oncology&amp;HdCorpBD · officer1
Nadim AhmedCEO, Cullinan1
Nadim AhmedPresident and CEO · director and officer1
Natalie Anne Marie FurneyGlobal General Counsel · officer1
Nathan L. MataChief Scientific Officer · officer1
Neda Aghajani MemarSenior Director, Global Regulatory Affairs · regulatory1
Neil KumarChief Executive Officer · director and officer1
Nevan C Elamdirector · director1
Nicola Deidre Petal GreenwayChief Human Resources Officer · officer1
Pamela J. Craigdirector · director1
Patricia F Russodirector · director1
Patrik JonssonEVP &amp; President, LLY Int'l · officer1
Paul Edward Walkerten percent owner · ten percent owner1
Paul Gisbert Auwaerterdirector · director1
Paul Rothmandirector · director1
Paulus Stoffelsdirector · director1
Peng LuPresident · officer1
Peter Evan Harwindirector · director1
Philip J Gotwalsdirector · director1
Rachael Easton, MD, Ph.D.study director, Cogent Biosciences, Inc. · researcher1
Ralph Alvarezdirector · director1
Ramy Riad Ahmed IbrahimPresident, PDT BU · officer1
Randal W. Scottdirector · director1
Rashmi Virendra RamchandaniVP, Chief Accounting Officer · officer1
Raymond Dennis PrattChief Medical Officer · officer1
Rhonda Janice PachecoPresident, U.S. Business Unit · officer1
Richard A Meierdirector · director1
Richard Brudnickdirector · director1
Richard J Hawkinsdirector · director1
Richard R. DeLucaEVP&amp;Pres, Merck Animal Heallth · officer1
Rick Yangten percent owner · ten percent owner1
Ricky Sundirector · director1
Risa J Lavizzo-moureydirector · director1
Robert Glassmandirector · director1
Robert J. Hombachdirector · director1
Robert M DavisChairman, CEO &amp; President · director and officer1
Robert M Plengedirector · director1
Robert Matthew LutzChief Fin. &amp; Operating Officer · officer1
Ronald J Danielsdirector · director1
Sanat ChattopadhyayExe V-P &amp; Pres. MMD · officer1
Sarah A O'Dowddirector · director1
Scott D Sandellten percent owner · ten percent owner1
Shehnaaz Sulimandirector · director1
Srinivas Akkarajudirector · director2
Stephen Mayodirector · director1
Stephen W Websterdirector · director1
Steven Gillisdirector · director1
Surendralal Lanca Karsanbhaidirector · director1
Teresa Marie BitettiPresident, OBU · officer1
Theodore Alan HuizengaSVP, Chief Accounting Officer · officer1
Thomas H Glocerdirector · director1
Thomas TrimarchiPresident and CFO · officer1
Timothy P Walbertdirector · director1
Todd Shegogdirector · director1
Vikas SinhaChief Financial Officer · officer1
Viviane Mongesdirector · director1
Wan-Shan Chendirector · director1
Willard H Deredirector · director1
William D. Waddilldirector · director1
William J Chasedirector · director1
William R Jellisondirector · director1
Wim SouverijnsChief Commercial Officer · officer1
Xiao-Hui Chendirector · director1
Yasmine WasfiChief Medical Officer · officer1
Yoshiaki Fujimoridirector · director1
Yu-Hsin LinChief Executive Officer · director and officer1
Zosia Piotrowska, MDstudy chair, Massachusetts General Hospital · researcher1
Regulator · 1
US FDA30
Manufacturing site · 4
BioMarin, Galli Drive2
BioMarin, Shanbally2
Fujifilm Diosynth, Billingham1
Patheon, Ferentino1
Registrational trial · 77
ACHIEVE-41
ADVANCE1
APEX2
ATTAIN-11
ATTAIN-21
ATTAIN-CN1
ATTAIN-J1
ATTAIN-NOW1
ATTAIN-OSA1
Advance-HTN1
Bax241
BaxAsia1
BaxDuo-Pacific1
BaxHTN1
BaxNoD1
CHAPTER-31
CHAPTER-41
CREAATE1
ChonDRAgon1
DRAGON1
DRAGON II1
EASSI1
EMBOLD1
Essential31
FAST21
FORTIFY1
GEMINI-11
HAELO1
HOPE-33
IDeate-Lung011
IDeate-Lung021
IMPALA-22
INO-3107 phase 1/2 study in RRP1
Launch-HTN1
LunAIRo1
NCT000976951
NCT009120931
NCT013866581
NCT031977661
NCT038887551
NCT058139251
NCT061314371
NCT062688731
NCT063881871
NCT064317761
NCT064708281
NCT065050311
NCT065849161
NCT066447811
NCT066729391
NCT067804491
NCT069257371
NCT069484351
NCT069724591
NCT069724721
NCT069937921
NCT070116671
NCT072532851
NCT073577661
NCT073637201
NCT075644141
PEAK1
PROPEL 31
RAPIDe-31
REDEFINE 11
REDEFINE 21
REDEFINE 61
REZILIENT12
REZILIENT31
REZILIENT41
SAPPHIRE1
SUMMIT1
SynAIRgy1
Transpher A1
VERIFY1
iMMagine-11
iMMagine-31
Regulatory events

Regulatory event timeline

Each row is an FDA action or a sponsor's announcement about a filing, oldest first. The event date is the date of the action or announcement itself. The last column gives the page each event was read from and the date KXCO read it, which is a separate date. Where no event date is recorded, the row says so.

Event dateEvent and filingEvent typeSource and date read
2011-08-25Approved
Icatibant (Firazyr)
FDA approvaldrugs.com ↗
Source read 2026-09-22
2023-03-06Partial clinical hold after a fatal liver injury, in place by 6 Mar 2023, lifted April 2023
Ozekibart
Safety finding reportedsec.gov ↗
Source read 2026-10-14
2023-08-01FDA request for preclinical fetal data
Lonvo-z
FDA information requestfiercebiotech.com ↗
Source read 2026-09-22
2025-04-25Complete response letter
Pixclara (floretyrosine F 18)
Complete response letterdownload.open.fda.gov ↗
Source read 2026-09-23
2025-05-27Refuse to File, insufficient CMC
Molgramostim
Refusal to filesec.gov ↗
Source read 2026-09-30
2025-07-07Complete response letter
Fayuvi (rebisufligene etisparvovec-hopf)
Complete response letterdownload.open.fda.gov ↗
Source read 2026-09-23
2025-07-09Complete response letter
Deramiocel
Complete response letterdownload.open.fda.gov ↗
Source read 2026-09-23
2025-09-22Complete response letter
Apitegromab (Isembyld)
Complete response letterdownload.open.fda.gov ↗
Source read 2026-09-23
2025-11-10Pre-license inspection of the San Diego facility (2025) ended with a Form 483; the FDA accepted all responses
Deramiocel
FDA inspection findingssec.gov ↗
Source read 2026-10-15
2025-12-29INO-3107 BLA accepted, standard review
INO-3107
Filing acceptedsec.gov ↗
Source read 2026-10-14
2025-12-29FDA questioned eligibility for accelerated approval
INO-3107
FDA information requestsec.gov ↗
Source read 2026-10-14
2025-12-29FDA not planning advisory committee
INO-3107
No advisory committee plannedsec.gov ↗
Source read 2026-10-14
2026-02-17FDA inspection findings at the contract manufacturer (Form 483, September 2025); resolved, per Apnimed's 10-Q of 8 September 2026
AD109 (Oxnimbi)
FDA inspection findingssec.gov ↗
Source read 2026-10-15
2026-02-20BLA accepted
Anito-cel
Filing acceptedsec.gov ↗
Source read 2026-10-21
2026-02-25Quimilza BLA accepted
Quimilza (imsidolimab)
Filing acceptedprnewswire.com ↗
Source read 2026-10-14
2026-03-06Day 74 letter: no advisory committee planned
Molgramostim
No advisory committee plannedinvestors.savarapharma.com ↗
Source read 2026-10-05
2026-03-06NDA accepted
Lorundrostat
Filing acceptedsec.gov ↗
Source read 2026-10-21
2026-03-16NonAdvSM NDA accepted
Bezuclastinib (NonAdvSM)
Filing acceptedsec.gov ↗
Source read 2026-10-05
2026-03-16FDA identified no review issues, no AdCom
Bezuclastinib (NonAdvSM)
No advisory committee plannedglobenewswire.com ↗
Source read 2026-10-05
2026-04-01Approved
Orforglipron (Foundayo)
FDA approvaldrugs.com ↗
Source read 2026-10-10
2026-04-06Relutrigine NDA accepted, priority review
Relutrigine
Filing acceptedsec.gov ↗
Source read 2026-10-14
2026-04-13Priority review granted, RTOR and Project Orbis
Ifinatamab deruxtecan
Filing acceptedmerck.com ↗
Source read 2026-09-22
2026-04-14Ulixacaltamide NDA accepted
Ulixacaltamide
Filing acceptedsec.gov ↗
Source read 2026-10-14
2026-04-14FDA not planning advisory committee
Ulixacaltamide
No advisory committee plannedsec.gov ↗
Source read 2026-10-14
2026-04-15PDUFA extended 3 months, major amendment
Molgramostim
Target date extendedinvestors.savarapharma.com ↗
Source read 2026-09-18
2026-05-15Approved
Baxdrostat (Baxfendy)
FDA approvaldrugs.com ↗
Source read 2026-09-22
2026-05-27FDA not planning advisory committee
BBP-418
No advisory committee plannedsec.gov ↗
Source read 2026-10-05
2026-05-28FDA identified no review issues, no AdCom
Bezuclastinib
No advisory committee planneddrugs.com ↗
Source read 2026-10-14
2026-05-28GIST NDA accepted, priority review
Bezuclastinib
Filing accepteddrugs.com ↗
Source read 2026-10-14
2026-06-15Ozekibart BLA accepted
Ozekibart
Filing acceptedsec.gov ↗
Source read 2026-10-14
2026-06-29PDUFA extended 3 months, major amendment
Relutrigine
Target date extendedsec.gov ↗
Source read 2026-10-14
2026-07-06NDA accepted
Deucrictibant IR
Filing acceptedir.pharvaris.com ↗
Source read 2026-09-22
2026-07-13sNDA for full approval accepted
Vosoritide (Voxzogo)
Filing acceptedinvestors.biomarin.com ↗
Source read 2026-10-21
2026-07-14AD109 NDA accepted
AD109 (Oxnimbi)
Filing accepteddrugs.com ↗
Source read 2026-10-14
2026-07-14FDA questions on the NDA's adequacy and requests for more data
AD109 (Oxnimbi)
FDA information requestsec.gov ↗
Source read 2026-10-14
2026-07-20FDA clinical inspection of HOPE-3, 6 to 20 July 2026, ended with a Form 483, one observation
Deramiocel
FDA inspection findingssec.gov ↗
Source read 2026-10-15
2026-07-29Advisory committee voted 9 to 3 against
Deramiocel
Advisory committee vote againstbiopharmadive.com ↗
Source read 2026-09-22
2026-08-05Approved
Oveporexton (Orzeyful)
FDA approvaldrugs.com ↗
Source read 2026-10-10
2026-08-06FDA not planning advisory committee
Relutrigine
No advisory committee plannedsec.gov ↗
Source read 2026-10-14
2026-08-11NDA accepted, priority review
Tinlarebant
Filing acceptedsec.gov ↗
Source read 2026-10-21
2026-08-13FDA inspection findings (Form 483), disclosed 13 Aug 2026
Ozekibart
FDA inspection findingssec.gov ↗
Source read 2026-10-14
2026-08-24PDUFA extended, indication narrowed
Deramiocel
Target date extendedcapricor.com ↗
Source read 2026-09-18
2026-08-28Approved
Rusfertide (Mimrylo)
FDA approvaldrugs.com ↗
Source read 2026-10-10
2026-09-01FDA not planning advisory committee
Lonvo-z
No advisory committee plannedir.intelliatx.com ↗
Source read 2026-09-22
2026-09-08BLA accepted, priority review
Lonvo-z
Filing acceptedir.intelliatx.com ↗
Source read 2026-09-22
2026-09-11Approved on the PDUFA date
Pixclara (floretyrosine F 18)
FDA approvaldrugs.com ↗
Source read 2026-09-22
2026-09-11Approved
Apitegromab (Isembyld)
FDA approvaldrugs.com ↗
Source read 2026-10-10
2026-09-15REZILIENT3 reported 3 deaths from septic shock
Zipalertinib
Safety finding reportedbiospace.com ↗
Source read 2026-09-22
2026-09-15AdvSM NDA accepted
Bezuclastinib (AdvSM)
Filing acceptedglobenewswire.com ↗
Source read 2026-10-05
2026-09-15FDA identified no review issues, no AdCom
Bezuclastinib (AdvSM)
No advisory committee plannedglobenewswire.com ↗
Source read 2026-10-05
2026-09-17Standard full approval, 2 days before the PDUFA date
Fayuvi (rebisufligene etisparvovec-hopf)
FDA approvaldrugs.com ↗
Source read 2026-09-22
2026-09-25BLA voluntarily withdrawn after discussions with the FDA
Ifinatamab deruxtecan
Application withdrawnmerck.com ↗
Source read 2026-10-04
2026-10-06Infigratinib NDA accepted, Priority Review
Infigratinib
Filing acceptedinvestor.bridgebio.com ↗
Source read 2026-10-10
2026-10-30Accelerated approval on the PDUFA date
INO-3107
FDA approvalir.inovio.com ↗
Source read 2026-10-31
Data coverage

184 of 200 data points recorded on the pending filings

Each row is a filing awaiting an FDA decision, and each column a kind of evidence a reader would want on it. Where a value is not recorded, the table says so rather than filling the gap. A missing value does not mean the regulatory risk is absent.

Recorded Not recordedThe last column counts the recorded values for each filing, and the bottom row counts the filings holding each kind.
FilingThe decision dayThe review typeA registered trialA trial resultAn FDA actionA market quoteOptions across the decisionThe sponsor's approval historyThe sponsor's peopleA signed callHeld
Capricor10 of 10
Savara10 of 10
BridgeBio10 of 10
Cogent Bio10 of 10
Vanda Pharmaceuticals9 of 10
Mineralys10 of 10
Arcellx7 of 10
Praxis Precision Medicines9 of 10
Cogent Bio10 of 10
Novo Nordisk5 of 10
Praxis Precision Medicines9 of 10
BridgeBio10 of 10
Belite Bio10 of 10
Otsuka (Taiho)9 of 10
Apnimed8 of 10
BioMarin9 of 10
Intellia10 of 10
Inhibrx Biosciences9 of 10
Pharvaris10 of 10
Cogent Bio10 of 10
filings holding it19202018191917201220

The widest gap is the sponsor's people, open on 8 of 20 filings. The next is options across the decision, open on 3.

Search the evidence

Search 520 source-linked claims

Search by drug, company, person, condition or phrase. Each result is a recorded claim, shown with the exact sentence it was read from, the web address of that page and the date it was read. The search returns recorded claims only. It does not write an answer. It covers the 32 drugs on this board, the companies behind them and the people in them, so a drug or company outside the board, such as Ozempic or Pfizer, returns nothing.

    Supporting documentation

    Every view behind the front page

    The front page draws on these views. Each one is built from the same record, and every figure in it shows its source.

    The opportunity and the decisions ahead
    The research calls and how they are tested
    Market expectations and upside
    The evidence
    The board and the record
    Source register

    646 source addresses, and every claim cites one

    Every claim shows the address it came from and the sentence read there. Each heading is one host. –: no claim cites it; its note says what it carries. Read: the day the address was last read, not the date of the event it reports or the time of a market quote.

    Source, by hostClaims citing itRead
    sec.gov · 439
    ANAPTYSBIO, INC, 10-Q filed 2022-11-08
    States the drug's other name in one sentence: ANB019.
    		–2026-10-20
    BridgeBio Pharma, Inc., 8-K filed 2026-07-02
    States the drug's other name in one sentence: ribitol.
    		–2026-10-20
    CAPRICOR THERAPEUTICS, INC., 8-K filed 2026-08-24
    States the drug's other name in one sentence: CAP-1002.
    		–2026-10-20
    Evidence for the signed call on BBP-418
    Read for the call ledger's feature drug not biologic.
    		–2026-10-05
    Evidence for the signed call on Deucrictibant IR
    Read for the call ledger's feature drug not biologic.
    		–2026-10-05
    Evidence for the signed call on Lonvo-z
    Read for the call ledger's feature drug not biologic.
    		–2026-10-05
    Evidence for the signed call on Lorundrostat
    Read for the call ledger's feature drug not biologic.
    		–2026-10-05
    Inovio Pharmaceuticals, Inc., 8-K filed 2026-11-02
    States the drug's other name in one sentence: VOCERYQ.
    		–2026-10-20
    Intellia Therapeutics, Inc., 8-K filed 2026-08-06
    States the drug's other name in one sentence: NTLA-2002.
    		–2026-10-20
    Pharvaris N.V., 6-K filed 2026-08-12
    States the drug's other name in one sentence: PHA121.
    		–2026-10-20
    Praxis Precision Medicines, Inc., 10-K filed 2025-02-28
    States the drug's other name in one sentence: PRAX-944.
    		–2026-10-20
    Praxis Precision Medicines, Inc., 8-K filed 2025-11-05
    States the drug's other name in one sentence: PRAX-562.
    		–2026-10-20
    Reported result, APEX
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, Advance-HTN
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, ChonDRAgon
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, EMBOLD
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, FORTIFY
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, GEMINI-1
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, INO-3107 phase 1/2 study in RRP
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, Launch-HTN
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, PEAK
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, PROPEL 3
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, SUMMIT
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    Reported result, iMMagine-1
    Quoted in the filing briefs' Registered trials table; the sentence found there word for word.
    		–2026-10-21
    SEC Form 4, BBIO, Apuli Maricel
    Filed 2026-11-03.
    		–2026-11-10
    SEC Form 4, BBIO, Kumar Neil
    Filed 2026-09-21.
    		–2026-11-10
    SEC Form 4, BBIO, Kumar Neil
    Filed 2026-08-20.
    		–2026-11-10
    SEC Form 4, BLTE, Chuang Hao-Yuan
    Filed 2026-09-09.
    		–2026-11-10
    SEC Form 4, BLTE, Chuang Hao-Yuan
    Filed 2026-08-14.
    		–2026-11-10
    SEC Form 4, BLTE, Lin Yu-Hsin
    Filed 2026-09-09.
    		–2026-11-10
    SEC Form 4, BLTE, Lin Yu-Hsin
    Filed 2026-08-14.
    		–2026-11-10
    SEC Form 4, BLTE, Scholl Hendrik Peter
    Filed 2026-10-05.
    		–2026-11-10
    SEC Form 4, BMRN, Davis George Eric
    Filed 2026-09-03.
    		–2026-11-10
    SEC Form 4, CGEM, Michaelson Jennifer
    Filed 2026-11-06.
    		–2026-11-10
    SEC Form 4, CGEM, Michaelson Jennifer
    Filed 2026-09-10.
    		–2026-11-10
    SEC Form 4, CGEM, Michaelson Jennifer
    Filed 2026-08-14.
    		–2026-11-10
    SEC Form 4, COGT, Morris Arlene
    Filed 2026-08-31.
    		–2026-11-10
    SEC Form 4, INBX, FORSYTH DOUGLAS
    Filed 2026-09-08.
    		–2026-11-10
    SEC Form 4, INBX, Kayyem Jon Faiz
    Filed 2026-09-23.
    		–2026-11-10
    SEC Form 4, INBX, Kayyem Jon Faiz
    Filed 2026-09-17.
    		–2026-11-10
    SEC Form 4, INBX, Kayyem Jon Faiz
    Filed 2026-09-08.
    		–2026-11-10
    SEC Form 4, INBX, Lappe Mark
    Filed 2026-10-14.
    		–2026-11-10
    SEC Form 4, INBX, Lappe Mark
    Filed 2026-09-28.
    		–2026-11-10
    SEC Form 4, INBX, Lappe Mark
    Filed 2026-09-08.
    		–2026-11-10
    SEC Form 4, INBX, MANHARD KIMBERLY
    Filed 2026-09-15.
    		–2026-11-10
    SEC Form 4, INBX, MANHARD KIMBERLY
    Filed 2026-09-10.
    		–2026-11-10
    SEC Form 4, MLYS, Congleton Jon
    Filed 2026-10-02.
    		–2026-11-10
    SEC Form 4, MLYS, Karydas Daphne
    Filed 2026-09-17.
    		–2026-11-10
    SEC Form 4, MLYS, Rodman David Malcom
    Filed 2026-08-12.
    		–2026-11-10
    SEC Form 4, MLYS, Slingsby Brian Taylor
    Filed 2026-09-24.
    		–2026-11-10
    SEC Form 4, MLYS, Warren Eric
    Filed 2026-09-22.
    		–2026-11-10
    SEC Form 4, MLYS, Warren Eric
    Filed 2026-08-25.
    		–2026-11-10
    SEC Form 4, NTLA, Dube Michael P
    Filed 2026-10-06.
    		–2026-11-10
    SEC Form 4, NTLA, LEONARD JOHN M
    Filed 2026-11-03.
    		–2026-11-10
    SEC Form 4, NTLA, LEONARD JOHN M
    Filed 2026-08-24.
    		–2026-11-10
    SEC Form 4, PHVS, Abele Stefan Andreas
    Filed 2026-09-17.
    		–2026-11-10
    SEC Form 4, PHVS, Bjork Elisabeth
    Filed 2026-09-21.
    		–2026-11-10
    SEC Form 4, PHVS, Glassman Robert
    Filed 2026-09-21.
    		–2026-11-10
    SEC Form 4, PHVS, Glassman Robert
    Filed 2026-09-17.
    		–2026-11-10
    SEC Form 4, PHVS, Glassman Robert
    Filed 2026-09-11.
    		–2026-11-10
    SEC Form 4, PHVS, Lesage Anne
    Filed 2026-09-21.
    		–2026-11-10
    SEC Form 4, PHVS, Lesage Anne
    Filed 2026-09-14.
    		–2026-11-10
    SEC Form 4, PHVS, Lu Peng
    Filed 2026-09-21.
    		–2026-11-10
    SEC Form 4, PHVS, Lu Peng
    Filed 2026-09-15.
    		–2026-11-10
    SEC Form 4, PHVS, Lu Peng
    Filed 2026-09-09.
    		–2026-11-10
    SEC Form 4, PHVS, Modig Berndt
    Filed 2026-09-15.
    		–2026-11-10
    SEC Form 4, PHVS, Modig Berndt
    Filed 2026-08-18.
    		–2026-11-10
    SEC Form 4, PHVS, Modig Berndt
    Filed as code M.
    		–2026-11-10
    SEC Form 4, PHVS, Monges Viviane
    Filed 2026-09-25.
    		–2026-11-10
    SEC Form 4, PHVS, Nassif David W.
    Filed 2026-09-23.
    		–2026-11-10
    SEC Form 4, PHVS, Schikan Johannes Gerardus Christiaan Petrus
    Filed 2026-09-24.
    		–2026-11-10
    SEC Form 4, PHVS, Schikan Johannes Gerardus Christiaan Petrus
    Filed 2026-09-21.
    		–2026-11-10
    SEC Form 4, PHVS, Souverijns Wim
    Filed 2026-09-16.
    		–2026-11-10
    SEC Form 4, VNDA, Duncan Charles Cliff
    Filed 2026-11-05.
    		–2026-11-10
    SEC XBRL company facts, BBIO
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, BLTE
    Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.
    		–2026-11-10
    SEC XBRL company facts, BMRN
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, CAPR
    Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.
    		–2026-11-10
    SEC XBRL company facts, CGEM
    Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.
    		–2026-11-10
    SEC XBRL company facts, COGT
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, INO
    Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.
    		–2026-11-10
    SEC XBRL company facts, MLYS
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, NTLA
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, PHVS
    Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.
    		–2026-11-10
    SEC XBRL company facts, PRAX
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, SVRA
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC XBRL company facts, VNDA
    Cash, investments, debt and operating cash flow as filed, period ending 2026-09-30.
    		–2026-11-10
    SEC fails-to-deliver data
    Continuous net settlement fails to deliver, published by the SEC; this read covers 2026-09-15 to 2026-10-14.
    		–2026-11-10
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    SEC filing, AGIOS PHARMACEUTICALS, INC., decision date 2027-02-01
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, ARGENX SE, decision date 2027-02-18
    Filed 2026-10-22, form 6-K.
    		–2026-11-10
    SEC filing, Apnimed, Inc., decision date 2027-02-28
    Filed 2026-09-08, form 8-K.
    		–2026-11-10
    SEC filing, Aquestive Therapeutics, Inc., decision date 2027-03-16
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, Aquestive Therapeutics, Inc., decision date 2027-03-23
    Filed 2026-11-03, form 8-K.
    		–2026-11-10
    SEC filing, Arcutis Biotherapeutics, Inc., decision date 2027-02-23
    Filed 2026-11-04, form 10-Q.
    		–2026-11-10
    SEC filing, Axsome Therapeutics, Inc., decision date 2027-05-01
    Filed 2026-11-02, form 8-K.
    		–2026-11-10
    SEC filing, BELITE BIO, INC, decision date 2027-02-12
    Filed 2026-09-08, form 6-K.
    		–2026-11-10
    SEC filing, BRISTOL MYERS SQUIBB CO, decision date 2027-03-11
    Filed 2026-10-29, form 10-Q.
    		–2026-11-10
    SEC filing, BridgeBio Pharma, Inc., decision date 2026-11-27
    Filed 2026-10-29, form 8-K.
    		–2026-11-10
    SEC filing, CORCEPT THERAPEUTICS INC, decision date 2026-12-17
    Filed 2026-11-03, form 8-K.
    		–2026-11-10
    SEC filing, CYTOKINETICS INC, decision date 2026-11-14
    Filed 2026-11-04, form 10-Q.
    		–2026-11-10
    SEC filing, Cogent Biosciences, Inc., decision date 2026-11-30
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, Dyne Therapeutics, Inc., decision date 2027-01-21
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, EXELIXIS, INC., decision date 2026-12-03
    Filed 2026-10-29, form 10-Q.
    		–2026-11-10
    SEC filing, EXELIXIS, INC., decision date 2027-03-03
    Filed 2026-10-29, form 8-K.
    		–2026-11-10
    SEC filing, Eton Pharmaceuticals, Inc., decision date 2027-05-28
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, GILEAD SCIENCES, INC., decision date 2027-02-02
    Filed 2026-10-30, form 10-Q.
    		–2026-11-10
    SEC filing, Harmony Biosciences Holdings, Inc., decision date 2027-04-01
    Filed 2026-11-04, form 8-K.
    		–2026-11-10
    SEC filing, INSMED Inc, decision date 2027-01-28
    Filed 2026-10-29, form 8-K.
    		–2026-11-10
    SEC filing, Immunome Inc., decision date 2027-04-28
    Filed 2026-11-09, form 8-K.
    		–2026-11-10
    SEC filing, Inhibrx Biosciences, Inc., decision date 2027-04-14
    Filed 2026-08-13, form 8-K.
    		–2026-11-10
    SEC filing, Intellia Therapeutics, Inc., decision date 2027-03-10
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, Jazz Pharmaceuticals plc, decision date 2027-04-16
    Filed 2026-11-02, form 8-K.
    		–2026-11-10
    SEC filing, Merck & Co., Inc., decision date 2027-03-22
    Filed 2026-11-04, form 10-Q.
    		–2026-11-10
    SEC filing, PALVELLA THERAPEUTICS, INC., decision date 2027-02-28
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, Pharming Group N.V., decision date 2027-01-30
    Filed 2026-10-27, form 6-K.
    		–2026-11-10
    SEC filing, PolyPid Ltd., decision date 2026-11-28
    Filed 2026-10-28, form 6-K.
    		–2026-11-10
    SEC filing, Praxis Precision Medicines, Inc., decision date 2026-12-27
    Filed 2026-11-09, form 8-K.
    		–2026-11-10
    SEC filing, Sanofi, decision date 2026-11-25
    Filed 2026-07-30, form 6-K.
    		–2026-11-10
    SEC filing, Sarepta Therapeutics, Inc., decision date 2027-02-28
    Filed 2026-11-05, form 10-Q.
    		–2026-11-10
    SEC filing, Summit Therapeutics Inc., decision date 2026-11-14
    Filed 2026-11-04, form 8-K.
    		–2026-11-10
    SEC filing, UroGen Pharma Ltd., decision date 2027-06-14
    Filed 2026-11-04, form 8-K.
    		–2026-11-10
    SEC filing, VERTEX PHARMACEUTICALS INC / MA, decision date 2026-11-30
    Filed 2026-11-03, form 10-Q.
    		–2026-11-10
    SEC filing, Verastem, Inc., decision date 2027-02-07
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, Viatris Inc, decision date 2026-12-27
    Filed 2026-08-06, form 8-K.
    		–2026-11-10
    SEC filing, Zenas BioPharma, Inc., decision date 2027-05-27
    Filed 2026-11-05, form 8-K.
    		–2026-11-10
    SEC filing, uniQure N.V., decision date 2027-05-01
    Filed 2026-11-04, form 8-K.
    		–2026-11-10
    Savara Inc, 10-Q filed 2026-08-11
    States the drug's other name in one sentence: MOLBREEVI.
    		–2026-10-20
    The sponsor's own announcement, Apitegromab (Isembyld)
    Quoted in the FDA's Own Words view beside the FDA's letter.
    		–2026-10-05
    The sponsor's own announcement, Deramiocel
    Quoted in the FDA's Own Words view beside the FDA's letter.
    		–2026-10-05
    The sponsor's own announcement, Pixclara (floretyrosine F 18)
    Quoted in the FDA's Own Words view beside the FDA's letter.
    		–2026-10-05
    AD109 (Oxnimbi)32026-10-14
    AD109 (Oxnimbi)12026-10-15
    Adam Scott Levy12026-09-23
    Adrienne S Brown12026-09-23
    Agosti Marcello Pignagnoli12026-09-23
    Akshay Vaishnaw12026-09-23
    Alexander Hardy12026-09-23
    Alexander M Gold12026-09-23
    Ali J. Satvat12026-09-23
    Amrit Ray12026-09-23
    Anat Hakim12026-09-23
    Andrea Ellis12026-09-23
    Andrew Lo12026-09-23
    Andrew R Allen12026-09-23
    Andrew R Robbins12026-09-23
    Andrew Stewart Plump12026-09-23
    Anito-cel12026-10-21
    Anito-cel12026-10-21
    Anna Nijdam12026-09-23
    Anne Erickson12026-09-23
    Anne Lesage12026-09-23
    Anne-Marie Martin12026-09-23
    Anthony Bergmann12026-09-23
    Anthony Rosenberg12026-09-23
    Arlene Morris12026-09-23
    Arturo Molina MD12026-09-23
    Asif Ali12026-09-23
    Asuka Miyabashira12026-09-23
    Athena Countouriotis12026-09-23
    Awny Samaan Botros Farajallah12026-09-23
    BBP-41812026-10-05
    Barbara W. Bodem12026-09-23
    Berndt Modig12026-09-23
    Betty D Larson12026-09-23
    Bezuclastinib (NonAdvSM)12026-10-20
    Bezuclastinib (NonAdvSM), Nonadvanced systemic mastocytosis42026-10-05
    BioMarin, Galli Drive, BioMarin, Shanbally42026-10-12
    Birgit C Schultes12026-09-23
    Braden C. Parker12026-09-23
    Brian Foard12026-09-23
    Brian Goff12026-09-23
    Brian Mueller12026-09-23
    Brian Taylor Slingsby12026-09-23
    Bruce D Broussard12026-09-23
    Bryan Giraudo12026-09-23
    Caroline Litchfield12026-09-23
    Caryn Parlavecchio12026-09-23
    Charles Greg Guyer12026-09-23
    Charles J Homcy12026-09-23
    Chirfi Guindo12026-09-23
    Christian Behrenbruch12026-09-23
    Christine E Seidman12026-09-23
    Christophe Pierre Weber12026-09-23
    Christopher W. Cain12026-09-23
    Cole Pinnow12026-09-23
    Conventional chondrosarcoma, Ozekibart42026-10-14
    Corazon (Corsee) D. Sanders12026-09-23
    Corrine Savill12026-09-23
    Cristin Hubbard12026-09-23
    Dalton E. Smart III12026-09-23
    Daniel G Welch12026-09-23
    Daniel Skovronsky12026-09-23
    Daphne Karydas12026-09-23
    Darren Charlton Smith12026-09-23
    Darren Joel Patti12026-09-23
    David A Ramsay12026-09-23
    David A Ricks12026-09-23
    David B Musket12026-09-23
    David D. Meek12026-09-23
    David E I Pyott12026-09-23
    David Hallal12026-09-23
    David L Lowrance12026-09-23
    David Lebwohl12026-09-23
    David Malcom Rodman12026-09-23
    David Michael Williams12026-09-23
    David N Gill12026-09-23
    David Norman Cade12026-09-23
    David P. Ryan12026-09-23
    David R. Maraldo12026-09-23
    David W. Nassif12026-09-23
    Dean Y Li12026-09-23
    Deborah Dunsire12026-09-23
    Dennis Karl Huang12026-09-23
    Deramiocel12026-10-15
    Deramiocel12026-10-15
    Derek DiRocco12026-09-23
    Deucrictibant IR, Deucrictibant XR, Icatibant (Firazyr)32026-09-30
    Dinesh V PH D Patel12026-09-23
    Diogo Rau12026-09-23
    Donald A Zakrowski12026-09-23
    Douglas A. Dachille12026-09-23
    Douglas M Baker JR12026-09-23
    Earl M Collier JR12026-09-23
    Edgardo Hernandez12026-09-23
    Edward J Dulac III12026-09-23
    Elaine J Heron12026-09-23
    Elaine Mary Shannon12026-09-23
    Eliana Clark12026-09-23
    Elisabeth Bjork12026-09-23
    Elizabeth M Anderson12026-09-23
    Emiko Higashi12026-09-23
    Emil D Kakkis12026-09-23
    Eric Aguiar12026-09-23
    Eric Crombez12026-09-23
    Eric Dozier12026-09-23
    Eric Warren12026-09-23
    Erik Harris12026-09-23
    Erin Burkhart12026-09-23
    Es-Johansson An van12026-09-23
    Essential tremor, Ulixacaltamide52026-10-14
    Evan Kearns12026-09-23
    Frank Litvack12026-09-23
    Frank Mccormick12026-09-23
    Frank Verwiel12026-09-23
    Fred E Cohen12026-09-23
    Fred Hassan12026-09-23
    Fujifilm Diosynth, Billingham, Patheon, Ferentino22026-10-12
    Gabriele Ricci12026-09-23
    Gabrielle Sulzberger12026-09-23
    Gary Clark Biddle12026-09-23
    Gaurav K Gupta12026-09-23
    Generalised pustular psoriasis, Quimilza (imsidolimab)22026-10-14
    George Eric Davis12026-09-23
    George W Dunbar JR12026-09-23
    Georgia Keresty12026-09-23
    Giles Richard Platford12026-09-23
    Glenn Sblendorio12026-09-23
    Gregory R Friberg12026-09-23
    Hannah Valantine12026-09-23
    Hao-Yuan Chuang12026-09-23
    Harold E Selick12026-09-23
    Hendrik Peter Scholl12026-09-23
    Henry J Fuchs12026-09-23
    Howard Horn12026-09-23
    INO-3107, Recurrent respiratory papillomatosis62026-10-14
    Ian T Clark22026-09-23
    Ilya Yuffa12026-09-23
    Inge G Thulin12026-09-23
    Ita Lu12026-09-23
    J Erik Fyrwald12026-09-23
    Jacquelyn L Sumer12026-09-23
    James Basta12026-09-23
    James C Momtazee12026-09-23
    James J. Ferguson III12026-09-23
    Jann Elizabeth Skinner12026-09-23
    Jean Luc Butel12026-09-23
    Jeffrey Alan Jones12026-09-23
    Jeffrey S. Flier12026-09-23
    Jennifer E. Cook12026-09-23
    Jennifer Marie Smoter12026-09-23
    Jennifer Michaelson12026-09-23
    Jennifer Zachary12026-09-23
    Jesse Goodman12026-09-23
    Jessica Sachs12026-09-23
    Jing L. Marantz12026-09-23
    Jochen Knolle12026-10-12
    Johannes Gerardus Christiaan Petrus Schikan12026-09-23
    Johannes Jacobus Oosthuizen12026-09-23
    John Edward Robinson12026-09-23
    John L. Green12026-09-23
    John M Leonard12026-09-23
    John Maraganore12026-09-23
    John Michael Longo12026-09-23
    John Richard Pinion12026-09-23
    Jon Congleton12026-09-23
    Joseph S McCracken12026-09-23
    Joshua Reed12026-09-23
    Juan R Luciano12026-09-23
    Julie So-Young Kim12026-09-23
    Junlin Ho12026-09-23
    Karah Herdman Parschauer12026-09-23
    Karen Jean Ferrante12026-09-23
    Karen Krasney12026-09-23
    Karimah Es Sabar12026-09-23
    Kathleen R. McCabe12026-09-23
    Kathy J Warden12026-09-23
    Katie Peng12026-09-23
    Keith Woods12026-09-23
    Kenneth L. Custer12026-09-23
    Kimberly A. Reed12026-09-23
    Koichiro Kimura12026-09-23
    Koji Hatsukawa12026-09-23
    Kristina Burow12026-09-23
    Lauren Rusckowski Duprey12026-09-23
    Lewis T Williams12026-09-23
    Linda Marban12026-09-23
    Lorundrostat12026-10-21
    Lorundrostat12026-10-21
    Lucas Montarce12026-09-23
    Mani Sharma12026-09-23
    Maria Rivas12026-09-23
    Maricel Apuli12026-09-23
    Marie Elizabeth McDonald12026-09-23
    Mark Alexander Nelson12026-09-23
    Mark J Enyedy12026-09-23
    Mary Ellen Coe12026-09-23
    Mary Kay Fenton12026-09-23
    Mary Thistle12026-09-23
    Masami Iijima12026-09-23
    Matthew K Fust12026-09-23
    Matthew Pauls12026-09-23
    Matthew Ros12026-09-23
    Maykin Ho12026-09-23
    Melissa Seymour12026-09-23
    Michael Gilman12026-09-23
    Michael Narachi12026-09-23
    Michael P Dube12026-09-23
    Michael T Maurer12026-09-23
    Michel Bruno Orsinger12026-09-23
    Mike Kelliher12026-09-23
    Miki Tsusaka12026-09-23
    Milano Furuta12026-09-23
    Mittie Doyle12026-09-23
    Mo Qatanani12026-09-23
    Molgramostim12026-09-30
    Muna Bhanji12026-09-23
    Naarden Jacob Van12026-09-23
    Nadim Ahmed12026-09-23
    Natalie Anne Marie Furney12026-09-23
    Nathan L. Mata12026-09-23
    Neil Kumar12026-09-23
    Nevan C Elam12026-09-23
    Nicola Deidre Petal Greenway12026-09-23
    Ozekibart12026-10-14
    Ozekibart12026-10-14
    Pamela J. Craig12026-09-23
    Patricia F Russo12026-09-23
    Patrik Jonsson12026-09-23
    Paul Gisbert Auwaerter12026-09-23
    Paul Rothman12026-09-23
    Paulus Stoffels12026-09-23
    Peng Lu12026-09-23
    Peter Evan Harwin12026-09-23
    Philip J Gotwals12026-09-23
    Quimilza (imsidolimab)12026-10-14
    Ralph Alvarez12026-09-23
    Ramy Riad Ahmed Ibrahim12026-09-23
    Randal W. Scott12026-09-23
    Rashmi Virendra Ramchandani12026-09-23
    Raymond Dennis Pratt12026-09-23
    Relutrigine32026-10-14
    Relutrigine12026-10-14
    Relutrigine, SCN2A and SCN8A developmental and epileptic encephalopathies22026-10-14
    Rhonda Janice Pacheco12026-09-23
    Richard A Meier12026-09-23
    Richard Brudnick12026-09-23
    Richard J Hawkins12026-09-23
    Richard R. DeLuca12026-09-23
    Ricky Sun12026-09-23
    Risa J Lavizzo-mourey12026-09-23
    Robert Glassman12026-09-23
    Robert J. Hombach12026-09-23
    Robert M Davis12026-09-23
    Robert M Plenge12026-09-23
    Robert Matthew Lutz12026-09-23
    Ronald J Daniels12026-09-23
    Sanat Chattopadhyay12026-09-23
    Sarah A O'Dowd12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Savara12026-09-23
    Shehnaaz Suliman12026-09-23
    Srinivas Akkaraju22026-09-23
    Stephen Mayo12026-09-23
    Stephen W Webster12026-09-23
    Steven Gillis12026-09-23
    Surendralal Lanca Karsanbhai12026-09-23
    Teresa Marie Bitetti12026-09-23
    Theodore Alan Huizenga12026-09-23
    Thomas H Glocer12026-09-23
    Thomas Trimarchi12026-09-23
    Timothy P Walbert12026-09-23
    Tinlarebant12026-10-21
    Todd Shegog12026-09-23
    Vikas Sinha12026-09-23
    Viviane Monges12026-09-23
    Wan-Shan Chen12026-09-23
    Willard H Dere12026-09-23
    William D. Waddill12026-09-23
    William J Chase12026-09-23
    William R Jellison12026-09-23
    Wim Souverijns12026-09-23
    Xiao-Hui Chen12026-09-23
    Yasmine Wasfi12026-09-23
    Yoshiaki Fujimori12026-09-23
    Yu-Hsin Lin12026-09-23
    Zipalertinib + chemotherapy (first line)12026-10-05
    clinicaltrials.gov · 90
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-20
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    ClinicalTrials.gov record
    Quoted in the filing briefs: what the trial measured, its patients, its control and its application.
    		–2026-10-21
    NCT00097695, a registration behind this board
    Status COMPLETED, enrolment 84, primary completion 2006-07-17. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT00500656, a registration behind this board
    Status COMPLETED, enrolment 85, primary completion 2006-07-25. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT00912093, a registration behind this board
    Status COMPLETED, enrolment 98, primary completion 2010-10-01. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT00997204, a registration behind this board
    Status COMPLETED, enrolment 151, primary completion 2011-06-22. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT01386658, a registration behind this board
    Status COMPLETED, enrolment 32, primary completion 2018-03-12. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT02716246, a registration behind this board
    Status RECRUITING, enrolment 36, primary completion 2029-03. Its registration agrees with this record on the name, the sponsor and the drug named in the registration.
    		–2026-10-21
    NCT03197766, a registration behind this board
    Status COMPLETED, enrolment 121, primary completion 2019-10-30. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT03888755, a registration behind this board
    Status COMPLETED, enrolment 8, primary completion 2016-02-12. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT04036682, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 284, primary completion 2025-10-13. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		12026-09-23
    NCT04398433, a registration behind this board
    Status COMPLETED, enrolment 32, primary completion 2022-12-15. Its registration agrees with this record on the enrolment, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT04544293, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 164, primary completion 2023-11-30. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		12026-09-23
    NCT04950075, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 206, primary completion 2025-09-30. Its registration agrees with this record on the name, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT04996875, a registration behind this board
    Status RECRUITING, enrolment 140, primary completion 2025-09-19. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		12026-09-23
    NCT05126758, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 106, primary completion 2025-06-18. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		22026-09-23
    NCT05156320, a registration behind this board
    Status COMPLETED, enrolment 188, primary completion 2024-12-18. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05186753, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 237, primary completion 2025-05-22. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-10-20
    NCT05208047, a registration behind this board
    Status RECRUITING, enrolment 482, primary completion 2025-09-30. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05210790, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 293, primary completion 2025-02-21. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT05244304, a registration behind this board
    Status COMPLETED, enrolment 104, primary completion 2025-08-04. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-09-23
    NCT05280470, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 187, primary completion 2025-03-03. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-09-23
    NCT05352893, a registration behind this board
    Status COMPLETED, enrolment 45, primary completion 2023-08-17. Its registration agrees with this record on the name, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT05394519, a registration behind this board
    Status COMPLETED, enrolment 1200, primary completion 2025-01-28. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05396885, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 136, primary completion 2026-12. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-10-21
    NCT05567796, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 3400, primary completion 2024-10-30. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05769608, a registration behind this board
    Status COMPLETED, enrolment 285, primary completion 2025-01-15. Its registration agrees with this record on the enrolment, the sponsor and the drug named in its title.
    		–2026-10-21
    NCT05775848, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 112, primary completion 2027-09. Its registration agrees with this record on the name and the drug named in its title.
    		–2026-09-23
    NCT05803421, a registration behind this board
    Status COMPLETED, enrolment 2749, primary completion 2026-03-16. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT05811247, a registration behind this board
    Status COMPLETED, enrolment 660, primary completion 2025-05-07. Its registration agrees with this record on the name, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT05813275, a registration behind this board
    Status COMPLETED, enrolment 646, primary completion 2025-03-10. Its registration agrees with this record on the name, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT05813925, a registration behind this board
    Status COMPLETED, enrolment 331, primary completion 2025-01-17. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05818553, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 77, primary completion 2025-11-12. Its registration agrees with this record on the name, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT05869903, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 3127, primary completion 2025-07-25. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05872620, a registration behind this board
    Status COMPLETED, enrolment 1613, primary completion 2025-08-08. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT05931380, a registration behind this board
    Status COMPLETED, enrolment 238, primary completion 2025-06-19. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT05973773, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 285, primary completion 2027-05-27. Its registration agrees with this record on the name and the drug named in its title.
    		–2026-09-23
    NCT05996848, a registration behind this board
    Status COMPLETED, enrolment 300, primary completion 2025-01-06. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06034743, a registration behind this board
    Status COMPLETED, enrolment 796, primary completion 2025-05-21. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06087276, a registration behind this board
    Status RECRUITING, enrolment 1000, primary completion 2025-10-10. Its registration agrees with this record on the name, the drug named in the registration and the sponsor.
    		12026-10-14
    NCT06131437, a registration behind this board
    Status COMPLETED, enrolment 809, primary completion 2025-12-08. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06153693, a registration behind this board
    Status COMPLETED, enrolment 1083, primary completion 2024-12-10. Its registration agrees with this record on the sponsor, the drug named in its title and the enrolment.
    		–2026-09-23
    NCT06164951, a registration behind this board
    Status COMPLETED, enrolment 114, primary completion 2025-12-18. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-10
    NCT06168409, a registration behind this board
    Status COMPLETED, enrolment 218, primary completion 2025-08-17. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06203210, a registration behind this board
    Status RECRUITING, enrolment 540, primary completion 2028-01-30. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06268873, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 2554, primary completion 2028-02-24. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06343779, a registration behind this board
    Status COMPLETED, enrolment 134, primary completion 2025-10-17. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-09-23
    NCT06344104, a registration behind this board
    Status COMPLETED, enrolment 326, primary completion 2025-11-24. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06388083, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 60, primary completion 2028-02. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT06388187, a registration behind this board
    Status COMPLETED, enrolment 300, primary completion 2026-04-22. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06413498, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 452, primary completion 2028-07. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06431776, a registration behind this board
    Status RECRUITING, enrolment 5, primary completion 2027-06. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT06470828, a registration behind this board
    Status COMPLETED, enrolment 168, primary completion 2025-06-03. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06505031, a registration behind this board
    Status COMPLETED, enrolment 105, primary completion 2025-06-04. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06584916, a registration behind this board
    Status COMPLETED, enrolment 376, primary completion 2025-11-21. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT06634420, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 80, primary completion 2026-02-10. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-09-23
    NCT06644781, a registration behind this board
    Status RECRUITING, enrolment 510, primary completion 2028-06-01. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06649045, a registration behind this board
    Status COMPLETED, enrolment 712, primary completion 2026-07-21. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06669754, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 81, primary completion 2026-08. Its registration agrees with this record on the name, the sponsor and the drug named in its title.
    		–2026-09-23
    NCT06672549, a registration behind this board
    Status RECRUITING, enrolment 125, primary completion 2027-02. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06672939, a registration behind this board
    Status RECRUITING, enrolment 150, primary completion 2027-12. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT06679881, a registration behind this board
    Status ENROLLING_BY_INVITATION, enrolment 170, primary completion 2028-12. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06742723, a registration behind this board
    Status RECRUITING, enrolment 5000, primary completion 2029-12-18. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06780449, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 400, primary completion 2028-08-28. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06925737, a registration behind this board
    Status RECRUITING, enrolment 1440, primary completion 2028-06-26. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06948435, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 487, primary completion 2027-09. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06972459, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 800, primary completion 2027-08. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06972472, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 600, primary completion 2027-08. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT06993792, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 1400, primary completion 2027-08. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT07011667, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 609, primary completion 2027-03-01. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07128199, a registration behind this board
    Status RECRUITING, enrolment 360, primary completion 2029-10-01. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-10-21
    NCT07253285, a registration behind this board
    Status RECRUITING, enrolment 460, primary completion 2030-03-20. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07266805, a registration behind this board
    Status RECRUITING, enrolment 48, primary completion 2027-06. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07357766, a registration behind this board
    Status WITHDRAWN, enrolment 0, primary completion 2027-11-29. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07363720, a registration behind this board
    Status ACTIVE_NOT_RECRUITING, enrolment 98, primary completion 2026-10-02. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07564414, a registration behind this board
    Status RECRUITING, enrolment 2500, primary completion 2028-02-23. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07686120, a registration behind this board
    Status NOT_YET_RECRUITING, enrolment 286, primary completion 2028-02-09. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07790861, a registration behind this board
    Status NOT_YET_RECRUITING, enrolment 192, primary completion 2028-03. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    NCT07794579, a registration behind this board
    Status RECRUITING, enrolment 2001, primary completion 2029-08. Its registration agrees with this record on the name, the drug named in its title and the sponsor.
    		12026-09-23
    api.fda.gov · 16
    Evidence for the signed call on AD109 (Oxnimbi)
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-14
    Evidence for the signed call on Anito-cel
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on BBP-418
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Bezuclastinib
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on CagriSema
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Deramiocel
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Deucrictibant IR
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on INO-3107
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-14
    Evidence for the signed call on Lonvo-z
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Lorundrostat
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Molgramostim
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Ozekibart
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-14
    Evidence for the signed call on Quimilza (imsidolimab)
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-14
    Evidence for the signed call on Relutrigine
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-14
    Evidence for the signed call on Tinlarebant
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    Evidence for the signed call on Zipalertinib
    Read for the call ledger's feature sponsor has approval.
    		–2026-10-05
    stockanalysis.com · 16
    Price at call, APMD
    Read 2026-10-14 02:30 UTC.
    		–2026-10-14
    Price at call, BBIO
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, BLTE
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, BMRN
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, CAPR
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, CGEM
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, COGT
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, INBX
    Read 2026-10-14 02:30 UTC.
    		–2026-10-14
    Price at call, INO
    Read 2026-10-14 02:30 UTC.
    		–2026-10-14
    Price at call, MLYS
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, NTLA
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, NVO
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, PHVS
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, PRAX
    Read 2026-10-14 02:30 UTC.
    		–2026-10-14
    Price at call, SVRA
    Read 2026-10-04 07:38 UTC.
    		–2026-10-05
    Price at call, VNDA
    Read 2026-10-14 02:30 UTC.
    		–2026-10-14
    cdn-api.cboe.com · 14
    Cboe delayed options quotes, BBIO
    At-the-money straddles either side of the decision, quote time 2026-11-10 00:36:02.
    		–2026-11-10
    Cboe delayed options quotes, BLTE
    At-the-money straddles either side of the decision, quote time 2026-11-09 21:52:52.
    		–2026-11-10
    Cboe delayed options quotes, BMRN
    At-the-money straddles either side of the decision, quote time 2026-11-09 21:24:37.
    		–2026-11-10
    Cboe delayed options quotes, CAPR
    At-the-money straddles either side of the decision, quote time 2026-11-09 22:29:44.
    		–2026-11-10
    Cboe delayed options quotes, CGEM
    At-the-money straddles either side of the decision, quote time 2026-11-09 11:08:07.
    		–2026-11-10
    Cboe delayed options quotes, COGT
    At-the-money straddles either side of the decision, quote time 2026-11-10 00:17:20.
    		–2026-11-10
    Cboe delayed options quotes, INBX
    At-the-money straddles either side of the decision, quote time 2026-11-10 00:06:14.
    		–2026-11-10
    Cboe delayed options quotes, MLYS
    At-the-money straddles either side of the decision, quote time 2026-11-09 23:42:58.
    		–2026-11-10
    Cboe delayed options quotes, NTLA
    At-the-money straddles either side of the decision, quote time 2026-11-10 00:07:29.
    		–2026-11-10
    Cboe delayed options quotes, NVO
    At-the-money straddles either side of the decision, quote time 2026-11-09 23:50:48.
    		–2026-11-10
    Cboe delayed options quotes, PHVS
    At-the-money straddles either side of the decision, quote time 2026-11-10 00:38:02.
    		–2026-11-10
    Cboe delayed options quotes, PRAX
    At-the-money straddles either side of the decision, quote time 2026-11-09 21:53:57.
    		–2026-11-10
    Cboe delayed options quotes, SVRA
    At-the-money straddles either side of the decision, quote time 2026-11-09 23:22:32.
    		–2026-11-10
    Cboe delayed options quotes, VNDA
    At-the-money straddles either side of the decision, quote time 2026-11-09 18:31:56.
    		–2026-11-10
    query1.finance.yahoo.com · 12
    Yahoo Finance daily closes, AZN around 2026-05-15
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, CAPR around 2025-07-11
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, INO around 2026-10-30
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, LLY around 2026-04-01
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, PTGX around 2026-08-28
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, RARE around 2025-07-11
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, RARE around 2026-09-17
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, SRRK around 2025-09-23
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, SRRK around 2026-09-11
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, TAK around 2026-08-05
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, TLX around 2025-04-28
    Closes either side of the announcement.
    		–2026-11-10
    Yahoo Finance daily closes, TLX around 2026-09-11
    Closes either side of the announcement.
    		–2026-11-10
    drugs.com · 10
    AD109 (Oxnimbi), Obstructive sleep apnoea22026-10-14
    Apitegromab (Isembyld), Spinal muscular atrophy42026-10-10
    Baxdrostat (Baxfendy)12026-09-22
    Bezuclastinib22026-10-14
    Fayuvi (rebisufligene etisparvovec-hopf), Sanfilippo syndrome Type A (MPS IIIA)52026-09-22
    Icatibant (Firazyr)12026-09-22
    Narcolepsy, Oveporexton (Orzeyful)42026-10-10
    Obesity, Orforglipron (Foundayo)42026-10-10
    Pixclara (floretyrosine F 18), Recurrent or progressive glioma imaging42026-09-22
    Polycythemia vera, Rusfertide (Mimrylo)42026-10-10
    download.open.fda.gov · 4
    Apitegromab (Isembyld), Complete response letter22026-09-23
    Complete response letter, Deramiocel22026-09-23
    Complete response letter, Fayuvi (rebisufligene etisparvovec-hopf)22026-09-23
    Complete response letter, Pixclara (floretyrosine F 18)22026-09-23
    globenewswire.com · 3
    Evidence for the signed call on CagriSema
    Read for the call ledger's feature drug not biologic.
    		–2026-10-05
    Advanced systemic mastocytosis, Bezuclastinib (AdvSM)52026-10-05
    Bezuclastinib (NonAdvSM)12026-10-05
    investor.bridgebio.com · 3
    Achondroplasia, Infigratinib42026-10-10
    BBP-41812026-09-18
    BBP-418, LGMD2I/R932026-09-22
    investors.savarapharma.com · 3
    Autoimmune PAP, Molgramostim22026-09-18
    Molgramostim12026-09-18
    Molgramostim12026-10-05
    ir.intelliatx.com · 3
    Hereditary angioedema, Lonvo-z42026-09-22
    John Leonard12026-09-18
    Lonvo-z12026-09-18
    ir.pharvaris.com · 3
    Deucrictibant IR12026-09-18
    Deucrictibant IR, Hereditary angioedema42026-09-22
    Deucrictibant XR, Hereditary angioedema32026-09-18
    biospace.com · 2
    Nadim Ahmed12026-09-18
    Zipalertinib22026-09-22
    ir.mineralystx.com · 2
    Lorundrostat12026-09-30
    Lorundrostat, Resistant hypertension32026-09-22
    merck.com · 2
    Extensive-stage SCLC, 2L, Ifinatamab deruxtecan52026-09-22
    Ifinatamab deruxtecan12026-10-04
    prnewswire.com · 2
    CagriSema, Obesity32026-09-22
    Quimilza (imsidolimab)12026-10-14
    advisory.avalerehealth.com · 1
    the FDA complete response letter base rate
    The cohort base rate behind the Regulatory standing and upside view: 37 percent of BLAs and NDAs took a complete response letter in the 2018 to 2022 PDUFA cycle.
    		–2026-11-10
    ascopubs.org · 1
    Ifinatamab deruxtecan12026-09-18
    astrazeneca.com · 1
    Baxdrostat (Baxfendy), Lorundrostat, Resistant hypertension42026-09-22
    biopharmadive.com · 1
    Deramiocel12026-09-22
    capricor.com · 1
    Deramiocel, Duchenne muscular dystrophy32026-09-18
    cgtlive.com · 1
    Deramiocel22026-09-22
    fiercebiotech.com · 1
    Lonvo-z22026-09-22
    finra.org · 1
    FINRA consolidated short interest
    Shares sold short at each twice-monthly settlement, with days to cover and the change, read by FINRA's public API.
    		–2026-11-10
    investors.belitebio.com · 1
    Stargardt disease type 1, Tinlarebant42026-09-22
    investors.biomarin.com · 1
    Achondroplasia, Vosoritide (Voxzogo)42026-10-21
    investors.cogentbio.com · 1
    Bezuclastinib, Bezuclastinib (AdvSM), GIST and systemic mastocytosis42026-09-22
    ir.inovio.com · 1
    INO-310712026-10-31
    mineralystx.com · 1
    Jon Congleton12026-09-18
    oindpnews.com · 1
    Molgramostim12026-09-22
    onclive.com · 1
    Zipalertinib12026-09-18
    open.fda.gov · 1
    the FDA's Complete Response Letter database
    The library behind the Letters view: 458 published letters, 309 on applications later approved and 149 still unapproved, last updated 2026-08-13. Queried through https://api.fda.gov/transparency/crl.json.
    		–2026-09-23
    pharvaris.com · 1
    Berndt Modig, Hereditary angioedema, Icatibant (Firazyr)52026-10-10
    pubmed.ncbi.nlm.nih.gov · 1
    Molgramostim12026-09-18
    savarapharma.com · 1
    Matt Pauls12026-09-18
    seekingalpha.com · 1
    Zipalertinib12026-09-18
    taihooncology.com · 1
    EGFR ex20ins NSCLC, Zipalertinib42026-10-12
    tipranks.com · 1
    Anito-cel, Relapsed or refractory multiple myeloma, 4L32026-09-22
    KXCO Round Table · as of 2026-10-31, derived from the latest recorded claim rather than stamped · every status checked 2026-11-10 · handling: public. Open to anyone, not indexed: the site sends a noindex header. Nothing here is investment advice or a recommendation.