{
"meta": {
"subject": "Every FDA decision on the board from October 2026 to April 2027, as a sourced record rather than a calendar",
"premise": "regulatory execution",
"as_of": "2026-10-05",
"as_of_basis": "derived from max(recorded_at) across the claim ledger",
"checked": "2026-10-05",
"market_as_of": "2026-10-04 07:38 UTC",
"room": {
"name": "FDA approval board",
"id": "fda",
"documents": 523
},
"rule": "Every edge is a claim and every claim carries the address it came from and the words it was read from. Where the record does not hold something, the room says so rather than filling it. This room carries no ranking model: it had one, the one term with any weight in it turned out to count how many trials a sponsor could afford, and it was withdrawn rather than repaired. The board is ordered by regulatory standing and implied upside, from dated events.",
"counts": {
"entities": 454,
"claims": 467,
"sources": 523,
"timeline": 31,
"drugs": 25,
"object_types": 7,
"link_types": 11,
"by_type": {
"drug": 25,
"company": 23,
"indication": 19,
"person": 280,
"trial": 75,
"event": 31,
"regulator": 1
},
"by_group": {
"own": 26,
"file": 1,
"ind": 24,
"prec": 3,
"team": 6,
"track": 2,
"ev": 75,
"reg": 54,
"people": 276
},
"recorded_on_as_of": 13,
"carried_forward": 454,
"recorded_on_build_date": 13,
"findings": 8
}
},
"model": {
"object_types": [
{
"id": "drug",
"label": "Drug candidate",
"color": "#c9a227",
"properties": [
{
"key": "pdufa",
"label": "PDUFA date",
"dataType": "string"
},
{
"key": "review",
"label": "Review type",
"dataType": "string",
"enumValues": [
"priority",
"standard",
"rtor",
"none"
]
},
{
"key": "status",
"label": "Status",
"dataType": "string",
"enumValues": [
"pending",
"approved",
"excluded",
"not_filed",
"withdrawn",
"overdue"
]
},
{
"key": "modality",
"label": "Modality",
"dataType": "string"
},
{
"key": "decided_on",
"label": "Date the FDA actually decided",
"dataType": "string",
"note": "Distinct from pdufa, which is the target. Present only once a decision landed."
},
{
"key": "pdufa_precision",
"label": "Precision of the PDUFA value",
"dataType": "string",
"enumValues": [
"day",
"quarter",
"not_filed"
]
},
{
"key": "withdrawn_on",
"label": "Date the sponsor withdrew the application",
"dataType": "string",
"note": "Added 4 Oct 2026. A withdrawal is the sponsor's act, not an FDA decision, so it is never written to decided_on and never counted as an approval or a refusal."
},
{
"key": "pathway",
"label": "Approval pathway the sponsor states",
"dataType": "string",
"enumValues": [
"accelerated",
"full",
"conversion_to_full",
"not_stated"
],
"note": "Added 5 Oct 2026. Anything but not_stated must carry pathway_src and pathway_quote. The FDA told Daiichi Sankyo and Merck the I-DXd data did not support accelerated approval; zipalertinib monotherapy is filed on the same pathway."
},
{
"key": "review_basis",
"label": "What the review designation rests on",
"dataType": "string",
"note": "Added 5 Oct 2026. Sponsors announce priority review and never standard, so a standard on the clock is inferred and must say so."
},
{
"key": "manufacturing",
"label": "Who makes it, per the sponsor",
"dataType": "list",
"note": "Added 5 Oct 2026, for biologics on the clock. Each item carries src and a verbatim quote."
}
]
},
{
"id": "company",
"label": "Public company",
"color": "#2f4f6f",
"properties": [
{
"key": "ticker",
"label": "Ticker",
"dataType": "string"
},
{
"key": "mcap_usd",
"label": "Market cap USD",
"dataType": "number"
},
{
"key": "price",
"label": "Share price USD",
"dataType": "number"
},
{
"key": "target",
"label": "Consensus target",
"dataType": "number"
},
{
"key": "upside_pct",
"label": "Upside percent",
"dataType": "number"
},
{
"key": "currency",
"enumValues": [
"USD",
"JPY"
]
}
]
},
{
"id": "indication",
"label": "Indication",
"color": "#6f4f2f",
"properties": [
{
"key": "unmet",
"label": "Existing therapy",
"dataType": "string"
}
]
},
{
"id": "person",
"label": "Executive",
"color": "#4f6f4f",
"properties": [
{
"key": "role",
"label": "Role",
"dataType": "string"
},
{
"key": "sec_cik"
},
{
"key": "kind"
},
{
"key": "titles"
},
{
"key": "career"
},
{
"key": "career_count"
},
{
"key": "career_truncated"
},
{
"key": "first_filed"
},
{
"key": "is_director"
},
{
"key": "is_officer"
},
{
"key": "affiliation"
},
{
"key": "career_src"
},
{
"key": "source_kind",
"enumValues": [
"sec_ownership_filing",
"trial_registration",
"fda_letter",
"press"
]
}
]
},
{
"id": "trial",
"label": "Registrational trial",
"color": "#6f2f4f",
"properties": [
{
"key": "n",
"label": "Enrolment",
"dataType": "number"
},
{
"key": "result",
"label": "Result",
"dataType": "string"
},
{
"key": "nct"
},
{
"key": "registry_status"
},
{
"key": "registry_enrolment"
},
{
"key": "primary_completion"
},
{
"key": "registry_url"
},
{
"key": "registry_checked"
},
{
"key": "registry_agreed_on"
},
{
"key": "registry_phase"
},
{
"key": "registry_state"
},
{
"key": "registry_why"
}
]
},
{
"id": "event",
"label": "Regulatory event",
"color": "#8f2f2f",
"properties": [
{
"key": "date",
"label": "Date",
"dataType": "string"
},
{
"key": "kind",
"label": "Kind",
"dataType": "string",
"enumValues": [
"rtf",
"crl",
"extension",
"acceptance",
"approval",
"info_request",
"adcom_declined",
"adcom_against",
"safety_signal",
"withdrawal"
]
},
{
"key": "letter_date"
},
{
"key": "application"
},
{
"key": "announced_on"
},
{
"key": "date_basis",
"enumValues": [
"fda_letter",
"sponsor_announcement",
"trade_press"
]
},
{
"key": "fda_sections"
}
]
},
{
"id": "regulator",
"label": "Regulator",
"color": "#333333",
"properties": []
}
],
"link_types": [
{
"id": "owns",
"label": "owns",
"inverseLabel": "is owned by",
"sources": [
"company"
],
"targets": [
"drug"
],
"cardinality": "MANY_TO_MANY",
"note": "Relaxed from ONE_TO_MANY on 22 Sep 2026. Co-development and co-commercialisation are normal for large assets, and ifinatamab deruxtecan is held by Daiichi Sankyo and Merck together. The model was wrong, not the data."
},
{
"id": "files_for",
"label": "files for",
"inverseLabel": "is filed by",
"sources": [
"company"
],
"targets": [
"drug"
],
"cardinality": "ONE_TO_MANY"
},
{
"id": "treats",
"label": "treats",
"inverseLabel": "is treated by",
"sources": [
"drug"
],
"targets": [
"indication"
],
"cardinality": "MANY_TO_MANY"
},
{
"id": "employs",
"label": "employs",
"inverseLabel": "is employed by",
"sources": [
"company"
],
"targets": [
"person"
],
"cardinality": "MANY_TO_MANY",
"note": "Relaxed from ONE_TO_MANY on 23 September 2026. A director sits on several boards, which the original cardinality declared impossible."
},
{
"id": "previously_shipped",
"label": "previously shipped",
"inverseLabel": "was shipped by",
"sources": [
"person"
],
"targets": [
"drug"
],
"cardinality": "MANY_TO_MANY"
},
{
"id": "evidences",
"label": "evidences",
"inverseLabel": "is evidenced by",
"sources": [
"trial"
],
"targets": [
"drug"
],
"cardinality": "MANY_TO_ONE"
},
{
"id": "precedent_for",
"label": "is precedent for",
"inverseLabel": "relies on precedent",
"sources": [
"drug"
],
"targets": [
"drug"
],
"cardinality": "ONE_TO_MANY"
},
{
"id": "acted_on",
"label": "acted on",
"inverseLabel": "was subject to",
"sources": [
"event"
],
"targets": [
"drug"
],
"cardinality": "MANY_TO_ONE"
},
{
"id": "decides_on",
"label": "decides on",
"inverseLabel": "is decided by",
"sources": [
"regulator"
],
"targets": [
"drug"
],
"cardinality": "ONE_TO_MANY"
},
{
"id": "directed",
"label": "Directed the trial",
"sources": [
"person"
],
"targets": [
"trial"
],
"cardinality": "MANY_TO_MANY"
},
{
"id": "named_on",
"label": "Named on the FDA letter",
"sources": [
"person"
],
"targets": [
"event"
],
"cardinality": "MANY_TO_MANY"
}
]
},
"nodes": [
{
"id": "idxd",
"label": "Ifinatamab deruxtecan",
"kind": "drug",
"sub": "PDUFA 2026-10-10 · withdrawn · rtor review",
"note": "Modality: ADC.",
"components": {
"trials": 4,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
},
"not_ranked_because": "Withdrawn by its sponsors on 2026-09-25, before the FDA decided. No decision will be made on this filing."
},
{
"id": "vosoritide",
"label": "Vosoritide (Voxzogo)",
"kind": "drug",
"sub": "PDUFA 2027-02-28 · pending · standard review",
"note": "Modality: peptide.",
"components": {
"trials": 2,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "lorundrostat",
"label": "Lorundrostat",
"kind": "drug",
"sub": "PDUFA 2026-12-22 · pending · standard review",
"note": "Modality: small molecule.",
"components": {
"trials": 1,
"precedent": 1,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "molgramostim",
"label": "Molgramostim",
"kind": "drug",
"sub": "PDUFA 2026-11-22 · pending · priority review",
"note": "Modality: inhaled protein.",
"components": {
"trials": 1,
"precedent": 0,
"closed_loop": 0,
"adverse": 2
}
},
{
"id": "bezuclastinib",
"label": "Bezuclastinib",
"kind": "drug",
"sub": "PDUFA 2026-11-30 · pending · priority review",
"note": "Modality: small molecule.",
"components": {
"trials": 2,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "cagrisema",
"label": "CagriSema",
"kind": "drug",
"sub": "PDUFA 2026-Q4 · pending · standard review",
"note": "Modality: peptide combo.",
"components": {
"trials": 19,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "zipalertinib",
"label": "Zipalertinib",
"kind": "drug",
"sub": "PDUFA 2027-02-27 · pending · standard review",
"note": "Modality: small molecule.",
"components": {
"trials": 2,
"precedent": 0,
"closed_loop": 0,
"adverse": 1
}
},
{
"id": "tinlarebant",
"label": "Tinlarebant",
"kind": "drug",
"sub": "PDUFA 2027-02-12 · pending · priority review",
"note": "Modality: small molecule.",
"components": {
"trials": 2,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "lonvo_z",
"label": "Lonvo-z",
"kind": "drug",
"sub": "PDUFA 2027-03-10 · pending · priority review",
"note": "Modality: in vivo CRISPR.",
"components": {
"trials": 1,
"precedent": 0,
"closed_loop": 0,
"adverse": 1
}
},
{
"id": "bbp_418",
"label": "BBP-418",
"kind": "drug",
"sub": "PDUFA 2026-11-27 · pending · priority review",
"note": "Modality: small molecule.",
"components": {
"trials": 1,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "deucrictibant",
"label": "Deucrictibant IR",
"kind": "drug",
"sub": "PDUFA 2027-04-23 · pending · standard review",
"note": "Modality: oral small molecule.",
"components": {
"trials": 3,
"precedent": 1,
"closed_loop": 2,
"adverse": 0
}
},
{
"id": "deramiocel",
"label": "Deramiocel",
"kind": "drug",
"sub": "PDUFA 2026-11-22 · excluded · standard review",
"note": "Modality: cell therapy.",
"components": {
"trials": 1,
"precedent": 0,
"closed_loop": 0,
"adverse": 3
}
},
{
"id": "baxdrostat",
"label": "Baxdrostat (Baxfendy)",
"kind": "drug",
"sub": "approved · priority review",
"note": "Modality: small molecule.",
"components": {
"trials": 9,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "icatibant",
"label": "Icatibant (Firazyr)",
"kind": "drug",
"sub": "approved",
"note": "Modality: peptide.",
"components": {
"trials": 1,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "orforglipron",
"label": "Orforglipron (Foundayo)",
"kind": "drug",
"sub": "approved · standard review",
"note": "Modality: oral small molecule.",
"components": {
"trials": 18,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "oveporexton",
"label": "Oveporexton (Orzeyful)",
"kind": "drug",
"sub": "approved · priority review",
"note": "Modality: small molecule.",
"components": {
"trials": 3,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "rusfertide",
"label": "Rusfertide (Mimrylo)",
"kind": "drug",
"sub": "approved · priority review",
"note": "Modality: peptide.",
"components": {
"trials": 0,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
}
},
{
"id": "apitegromab",
"label": "Apitegromab (Isembyld)",
"kind": "drug",
"sub": "approved · priority review",
"note": "Modality: antibody.",
"components": {
"trials": 2,
"precedent": 0,
"closed_loop": 0,
"adverse": 1
}
},
{
"id": "mrk",
"label": "Merck & Co",
"kind": "company",
"sub": "MRK",
"note": ""
},
{
"id": "bmrn",
"label": "BioMarin",
"kind": "company",
"sub": "BMRN",
"note": ""
},
{
"id": "mlys",
"label": "Mineralys",
"kind": "company",
"sub": "MLYS",
"note": ""
},
{
"id": "svra",
"label": "Savara",
"kind": "company",
"sub": "SVRA",
"note": ""
},
{
"id": "cogt",
"label": "Cogent Bio",
"kind": "company",
"sub": "COGT",
"note": ""
},
{
"id": "nvo",
"label": "Novo Nordisk",
"kind": "company",
"sub": "NVO",
"note": ""
},
{
"id": "cgem",
"label": "Cullinan",
"kind": "company",
"sub": "CGEM",
"note": ""
},
{
"id": "blte",
"label": "Belite Bio",
"kind": "company",
"sub": "BLTE",
"note": ""
},
{
"id": "ntla",
"label": "Intellia",
"kind": "company",
"sub": "NTLA",
"note": ""
},
{
"id": "bbio",
"label": "BridgeBio",
"kind": "company",
"sub": "BBIO",
"note": ""
},
{
"id": "phvs",
"label": "Pharvaris",
"kind": "company",
"sub": "PHVS",
"note": ""
},
{
"id": "capr",
"label": "Capricor",
"kind": "company",
"sub": "CAPR",
"note": ""
},
{
"id": "dsnky",
"label": "Daiichi Sankyo",
"kind": "company",
"sub": "TSE:4568",
"note": ""
},
{
"id": "otsuka",
"label": "Otsuka (Taiho)",
"kind": "company",
"sub": "TSE:4578",
"note": ""
},
{
"id": "azn",
"label": "AstraZeneca",
"kind": "company",
"sub": "AZN",
"note": ""
},
{
"id": "shire",
"label": "Jerini, acquired by Shire",
"kind": "company",
"sub": "private",
"note": ""
},
{
"id": "es_sclc",
"label": "Extensive-stage SCLC, 2L",
"kind": "indication",
"sub": "",
"note": "Existing therapy: limited."
},
{
"id": "achondro",
"label": "Achondroplasia",
"kind": "indication",
"sub": "",
"note": "Existing therapy: Voxzogo, Yuviwel."
},
{
"id": "res_htn",
"label": "Resistant hypertension",
"kind": "indication",
"sub": "",
"note": "Existing therapy: baxdrostat approved."
},
{
"id": "apap",
"label": "Autoimmune PAP",
"kind": "indication",
"sub": "",
"note": "Existing therapy: whole lung lavage only."
},
{
"id": "gist_sm",
"label": "GIST and systemic mastocytosis",
"kind": "indication",
"sub": "",
"note": "Existing therapy: partial."
},
{
"id": "obesity",
"label": "Obesity",
"kind": "indication",
"sub": "",
"note": "Existing therapy: crowded."
},
{
"id": "ex20ins",
"label": "EGFR ex20ins NSCLC",
"kind": "indication",
"sub": "",
"note": "Existing therapy: post-amivantamab gap."
},
{
"id": "stargardt",
"label": "Stargardt disease type 1",
"kind": "indication",
"sub": "",
"note": "Existing therapy: none approved."
},
{
"id": "hae",
"label": "Hereditary angioedema",
"kind": "indication",
"sub": "",
"note": "Existing therapy: several approved."
},
{
"id": "lgmd",
"label": "LGMD2I/R9",
"kind": "indication",
"sub": "",
"note": "Existing therapy: none approved."
},
{
"id": "dmd",
"label": "Duchenne muscular dystrophy",
"kind": "indication",
"sub": "",
"note": "Existing therapy: partial."
},
{
"id": "modig",
"label": "Berndt Modig",
"kind": "person",
"sub": "CEO, Pharvaris",
"note": ""
},
{
"id": "knolle",
"label": "Jochen Knolle",
"kind": "person",
"sub": "Co-founder and strategic advisor, Pharvaris; CSO and COO to end 2023",
"note": ""
},
{
"id": "ahmed",
"label": "Nadim Ahmed",
"kind": "person",
"sub": "CEO, Cullinan",
"note": ""
},
{
"id": "leonard",
"label": "John Leonard",
"kind": "person",
"sub": "CEO, Intellia",
"note": ""
},
{
"id": "congleton",
"label": "Jon Congleton",
"kind": "person",
"sub": "CEO, Mineralys",
"note": ""
},
{
"id": "pauls",
"label": "Matt Pauls",
"kind": "person",
"sub": "CEO, Savara",
"note": ""
},
{
"id": "impala2",
"label": "IMPALA-2",
"kind": "trial",
"sub": "",
"note": "Result: primary met, DLCO +6.0pp wk24, p<0.001. Enrolment 164."
},
{
"id": "haelo",
"label": "HAELO",
"kind": "trial",
"sub": "",
"note": "Result: primary and all key secondaries met, 87% attack reduction. Enrolment 80."
},
{
"id": "launch_htn",
"label": "Launch-HTN",
"kind": "trial",
"sub": "",
"note": "Result: -11.7 mmHg placebo-adj wk12, p<0.0001, JAMA. Enrolment 1083."
},
{
"id": "rezilient1",
"label": "REZILIENT1",
"kind": "trial",
"sub": "",
"note": "Result: ORR 35%, mDOR 8.8 months. Enrolment 176."
},
{
"id": "rezilient3",
"label": "REZILIENT3",
"kind": "trial",
"sub": "",
"note": "Result: 50% reduction in risk of progression, 1L. Enrolment 285."
},
{
"id": "rapide3",
"label": "RAPIDe-3",
"kind": "trial",
"sub": "",
"note": "Result: primary and all 11 secondaries met. Enrolment 134."
},
{
"id": "dragon",
"label": "DRAGON",
"kind": "trial",
"sub": "",
"note": "Result: 35.7% reduction in lesion growth. Enrolment 104."
},
{
"id": "ideate1",
"label": "IDeate-Lung01",
"kind": "trial",
"sub": "",
"note": "Result: ORR 48.2%. Enrolment 187."
},
{
"id": "fortify",
"label": "FORTIFY",
"kind": "trial",
"sub": "",
"note": "Result: interim consistent efficacy. Enrolment 112."
},
{
"id": "hope3",
"label": "HOPE-3",
"kind": "trial",
"sub": "",
"note": "Result: 54% slowing PUL decline p=0.029. Enrolment 106."
},
{
"id": "apex",
"label": "APEX",
"kind": "trial",
"sub": "",
"note": "Result: ORR 65%, CR 57%. Enrolment 140."
},
{
"id": "ev_svra_rtf",
"label": "Refuse to File, insufficient CMC",
"kind": "event",
"sub": "2025-05-27 · rtf",
"note": ""
},
{
"id": "ev_svra_ext",
"label": "PDUFA extended 3 months, major amendment",
"kind": "event",
"sub": "2026-04-15 · extension",
"note": ""
},
{
"id": "ev_ntla_fetal",
"label": "FDA request for preclinical fetal data",
"kind": "event",
"sub": "2023-08-01 · info_request",
"note": ""
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{
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{
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{
"id": "p_sec_0001820958",
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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"sub": "Chief Scientific Officer · officer",
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{
"id": "p_sec_0001782545",
"label": "Jessica Sachs",
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"sub": "Chief Medical Officer · officer",
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{
"id": "p_sec_0002014983",
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"sub": "director · director",
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{
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"label": "Johannes Jacobus Oosthuizen",
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"sub": "EVP, Oncology & Int?l · officer",
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{
"id": "p_sec_0001856514",
"label": "John Edward Robinson",
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{
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{
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{
"id": "p_sec_0002019493",
"label": "Michael P Dube",
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"sub": "VP, Chief Accounting Officer · officer",
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{
"id": "p_sec_0002013987",
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"sub": "Chief Scientific Officer · officer",
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{
"id": "p_sec_0001972159",
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"sub": "President · officer",
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{
"id": "p_sec_0002106034",
"label": "Rashmi Virendra Ramchandani",
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"sub": "VP, Chief Accounting Officer · officer",
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{
"id": "p_sec_0001897890",
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{
"id": "p_sec_0001164475",
"label": "Ronald J Daniels",
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"sub": "director · director",
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{
"id": "p_sec_0002030813",
"label": "Thomas Trimarchi",
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"sub": "President and CFO · officer",
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{
"id": "p_sec_0002001438",
"label": "Wan-Shan Chen",
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"sub": "director · director",
"note": ""
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{
"id": "p_sec_0001973529",
"label": "Wim Souverijns",
"kind": "person",
"sub": "Chief Commercial Officer · officer",
"note": ""
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{
"id": "p_sec_0002106182",
"label": "Xiao-Hui Chen",
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"sub": "director · director",
"note": ""
},
{
"id": "p_sec_0002092127",
"label": "Yasmine Wasfi",
"kind": "person",
"sub": "Chief Medical Officer · officer",
"note": ""
},
{
"id": "p_sec_0001965964",
"label": "Yu-Hsin Lin",
"kind": "person",
"sub": "Chief Executive Officer · director and officer",
"note": ""
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{
"id": "p_ct_NCT04544293_brucetrapnellm",
"label": "Bruce Trapnell, MD",
"kind": "person",
"sub": "principal investigator, Children's Hospital Medical Center, Cincinnati · researcher",
"note": ""
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{
"id": "p_ct_NCT04036682_zosiapiotrowsk",
"label": "Zosia Piotrowska, MD",
"kind": "person",
"sub": "study chair, Massachusetts General Hospital · researcher",
"note": ""
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{
"id": "p_ct_NCT05126758_craigmcdonaldm",
"label": "Craig McDonald, MD",
"kind": "person",
"sub": "principal investigator, University of California, Davis · researcher",
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},
{
"id": "p_ct_NCT05126758_markawadalla",
"label": "Mark Awadalla",
"kind": "person",
"sub": "study director, Capricor Inc. · researcher",
"note": ""
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{
"id": "p_ct_NCT04996875_rachaeleastonm",
"label": "Rachael Easton, MD, Ph.D.",
"kind": "person",
"sub": "study director, Cogent Biosciences, Inc. · researcher",
"note": ""
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{
"id": "p_crl_margaretkayophdm",
"label": "Margaret Kayo, PhD, MBA",
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"sub": "named on the FDA's letter to the sponsor · regulatory",
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{
"id": "p_crl_jadadaimi",
"label": "Jad Adaimi",
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"sub": "named on the FDA's letter to the sponsor · regulatory",
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},
{
"id": "p_crl_nedaaghajanimema",
"label": "Neda Aghajani Memar",
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"sub": "Senior Director, Global Regulatory Affairs · regulatory",
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{
"id": "p_crl_larahaddadrphrac",
"label": "Lara Haddad RPh, RAC",
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"sub": "Manager, Global Regulatory Affairs · regulatory",
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{
"id": "t_nct05156320",
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"sub": "",
"note": "Enrolment 188."
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{
"id": "t_nct05626855",
"label": "ONYX",
"kind": "trial",
"sub": "",
"note": "Enrolment 238."
},
{
"id": "t_nct06034743",
"label": "BaxHTN",
"kind": "trial",
"sub": "",
"note": "Enrolment 796."
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{
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"note": "Enrolment 218."
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{
"id": "t_nct06268873",
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"sub": "",
"note": "Enrolment 2554."
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{
"id": "t_nct06344104",
"label": "BaxAsia",
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"note": "Enrolment 326."
},
{
"id": "t_nct06677060",
"label": "Prevent-HF",
"kind": "trial",
"sub": "",
"note": "Enrolment 11300."
},
{
"id": "t_nct06742723",
"label": "BaxDuo-Pacific",
"kind": "trial",
"sub": "",
"note": "Enrolment 5000."
},
{
"id": "t_nct07007793",
"label": "BaxPA",
"kind": "trial",
"sub": "",
"note": "Enrolment 250."
},
{
"id": "t_nct07655362",
"label": "BaxREMODEL",
"kind": "trial",
"sub": "",
"note": "Enrolment 286."
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{
"id": "t_nct07686120",
"label": "BaxNoD",
"kind": "trial",
"sub": "",
"note": "Enrolment 286."
},
{
"id": "t_nct00997204",
"label": "EASSI",
"kind": "trial",
"sub": "",
"note": "Enrolment 151."
},
{
"id": "t_nct05869903",
"label": "ATTAIN-1",
"kind": "trial",
"sub": "",
"note": "Enrolment 3127."
},
{
"id": "t_nct05931380",
"label": "ATTAIN-J",
"kind": "trial",
"sub": "",
"note": "Enrolment 238."
},
{
"id": "t_nct06010004",
"label": "ACHIEVE-J",
"kind": "trial",
"sub": "",
"note": "Enrolment 401."
},
{
"id": "t_nct06045221",
"label": "ACHIEVE-3",
"kind": "trial",
"sub": "",
"note": "Enrolment 1698."
},
{
"id": "t_nct06109311",
"label": "ACHIEVE-5",
"kind": "trial",
"sub": "",
"note": "Enrolment 546."
},
{
"id": "t_nct06192108",
"label": "ACHIEVE-2",
"kind": "trial",
"sub": "",
"note": "Enrolment 962."
},
{
"id": "t_nct06649045",
"label": "ATTAIN-OSA",
"kind": "trial",
"sub": "",
"note": "Enrolment 712."
},
{
"id": "t_nct06672549",
"label": "ADVANCE",
"kind": "trial",
"sub": "",
"note": "Enrolment 125."
},
{
"id": "t_nct06948422",
"label": "NCT06948422",
"kind": "trial",
"sub": "",
"note": "Enrolment 974."
},
{
"id": "t_nct06948435",
"label": "NCT06948435",
"kind": "trial",
"sub": "",
"note": "Enrolment 487."
},
{
"id": "t_nct06972459",
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"kind": "trial",
"sub": "",
"note": "Enrolment 800."
},
{
"id": "t_nct06972472",
"label": "NCT06972472",
"kind": "trial",
"sub": "",
"note": "Enrolment 600."
},
{
"id": "t_nct07153471",
"label": "ATTAIN-OA PAIN",
"kind": "trial",
"sub": "",
"note": "Enrolment 800."
},
{
"id": "t_nct07202884",
"label": "RESTRAIN-SUI",
"kind": "trial",
"sub": "",
"note": "Enrolment 1000."
},
{
"id": "t_nct07223593",
"label": "ATTAIN-PAD",
"kind": "trial",
"sub": "",
"note": "Enrolment 1205."
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{
"id": "t_nct07668336",
"label": "ACHIEVE-PEDS",
"kind": "trial",
"sub": "",
"note": "Enrolment 170."
},
{
"id": "t_nct07790861",
"label": "ATTAIN-CN",
"kind": "trial",
"sub": "",
"note": "Enrolment 192."
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{
"id": "t_nct07794579",
"label": "ATTAIN-NOW",
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"sub": "",
"note": "Enrolment 2001."
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{
"id": "t_nct06470828",
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"kind": "trial",
"sub": "",
"note": "Enrolment 168."
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{
"id": "t_nct06505031",
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"sub": "",
"note": "Enrolment 105."
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{
"id": "t_nct07363720",
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"kind": "trial",
"sub": "",
"note": "Enrolment 98."
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{
"id": "t_nct06413498",
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"sub": "",
"note": "Enrolment 452."
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{
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"note": "Result: PFS HR 0.50, mPFS 16.5 v 9.2 months. Enrolment 482."
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{
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"note": "Enrolment 1200."
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{
"id": "t_nct05567796",
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"sub": "",
"note": "Enrolment 3400."
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{
"id": "t_nct05669755",
"label": "REDEFINE 3",
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"sub": "",
"note": "Enrolment 7101."
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{
"id": "t_nct05813925",
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"sub": "",
"note": "Enrolment 331."
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{
"id": "t_nct05996848",
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"sub": "",
"note": "Enrolment 300."
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{
"id": "t_nct06065540",
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"note": "Enrolment 2734."
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{
"id": "t_nct06131437",
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"sub": "",
"note": "Enrolment 809."
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{
"id": "t_nct06221969",
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"sub": "",
"note": "Enrolment 1024."
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{
"id": "t_nct06323161",
"label": "REIMAGINE 3",
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"sub": "",
"note": "Enrolment 274."
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{
"id": "t_nct06323174",
"label": "REIMAGINE 1",
"kind": "trial",
"sub": "",
"note": "Enrolment 189."
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{
"id": "t_nct06388187",
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"kind": "trial",
"sub": "",
"note": "Enrolment 300."
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{
"id": "t_nct06534411",
"label": "REIMAGINE 5",
"kind": "trial",
"sub": "",
"note": "Enrolment 1023."
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{
"id": "t_nct06780449",
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"kind": "trial",
"sub": "",
"note": "Enrolment 400."
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{
"id": "t_nct07011667",
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"kind": "trial",
"sub": "",
"note": "Enrolment 609."
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{
"id": "t_nct07253285",
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"kind": "trial",
"sub": "",
"note": "Enrolment 460."
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{
"id": "t_nct07282613",
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"sub": "",
"note": "Enrolment 80."
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{
"id": "t_nct07357766",
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"kind": "trial",
"sub": "",
"note": ""
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{
"id": "t_nct07564414",
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"kind": "trial",
"sub": "",
"note": "Enrolment 2500."
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{
"id": "t_nct07817251",
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"kind": "trial",
"sub": "",
"note": "Enrolment 210."
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{
"id": "t_nct06679881",
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"sub": "",
"note": "Enrolment 170."
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{
"id": "t_nct07266805",
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"sub": "",
"note": "Enrolment 48."
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{
"id": "t_nct06203210",
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"sub": "",
"note": "Enrolment 540."
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{
"id": "t_nct06644781",
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"kind": "trial",
"sub": "",
"note": "Enrolment 510."
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{
"id": "t_nct06925737",
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"kind": "trial",
"sub": "",
"note": "Enrolment 1440."
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{
"id": "t_nct05949593",
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"sub": "",
"note": "Enrolment 429."
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{
"id": "t_nct03197766",
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"kind": "trial",
"sub": "",
"note": "Enrolment 121."
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{
"id": "t_nct06455059",
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"sub": "",
"note": "Enrolment 80."
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"sub": "PDUFA 2027-06-29 · pending · standard review",
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{
"id": "ev_cogt_adv_acc",
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{
"id": "ev_cogt_adv_adcom",
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{
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"sub": "not_filed",
"note": "Modality: small molecule.",
"components": {
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},
"not_ranked_because": "Not filed. It carries no PDUFA date, so there is no decision to stand it beside."
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{
"id": "ev_bbio_adcom",
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"sub": "2026-05-27 · adcom_declined",
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{
"id": "ev_svra_day74",
"label": "Day 74 letter: no advisory committee planned",
"kind": "event",
"sub": "2026-03-06 · adcom_declined",
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],
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{
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"recorded_at": "2026-09-18",
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"recorded_at": "2026-09-18",
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{
"s": "cgem",
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"t": "zipalertinib",
"src": "taihooncology_us_food_and_drug_administration_accept",
"quote": "Taiho Oncology, Cullinan Therapeutics, and the FDA are working together",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "otsuka",
"p": "files_for",
"t": "zipalertinib",
"src": "taihooncology_us_food_and_drug_administration_accept",
"quote": "Taiho Oncology, Cullinan Therapeutics, and the FDA are working together throughout the review process",
"disc": "public",
"g": "file",
"conf": 0.9,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "blte",
"p": "owns",
"t": "tinlarebant",
"src": "investors_belite_bio_announces_us_food_and_drug",
"quote": "FDA has accepted and granted Priority Review designation of the NDA for tinlarebant",
"disc": "public",
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"conf": 1.0,
"recorded_at": "2026-09-18",
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},
{
"s": "ntla",
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"t": "lonvo_z",
"src": "ir_intellia_therapeutics_announces_fda_ac",
"quote": "FDA has accepted the BLA for lonvo-z and granted Priority Review",
"disc": "public",
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"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "bbio",
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"t": "bbp_418",
"src": "investor_default_aspx",
"quote": "FDA acceptance and priority review of NDA for BBP-418",
"disc": "public",
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"recorded_at": "2026-09-18",
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},
{
"s": "phvs",
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"t": "deucrictibant",
"src": "ir_pharvaris_announces_fda_acceptance_new",
"quote": "FDA acceptance of New Drug Application for deucrictibant IR",
"disc": "public",
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"recorded_at": "2026-09-18",
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},
{
"s": "capr",
"p": "owns",
"t": "deramiocel",
"src": "capricor_capricor_therapeutics_announces_extens",
"quote": "extension of PDUFA target action date as FDA continues review of deramiocel BLA",
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"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "azn",
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"t": "baxdrostat",
"src": "astrazeneca_baxdrostat_mnr_2026_html",
"quote": "Baxfendy approved in the US as the first and only aldosterone synthase inhibitor",
"disc": "public",
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"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "shire",
"p": "owns",
"t": "icatibant",
"src": "pharvaris_about_pharvaris",
"quote": "Jerini developed and launched icatibant for the treatment of HAE",
"disc": "public",
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"conf": 0.9,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "idxd",
"p": "treats",
"t": "es_sclc",
"src": "merck_ifinatamab_deruxtecan_granted_priority",
"quote": "extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "vosoritide",
"p": "treats",
"t": "achondro",
"src": "investors_default_aspx",
"quote": "for children with achondroplasia",
"disc": "public",
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"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "lorundrostat",
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"t": "res_htn",
"src": "ir_mineralys_therapeutics_announces_fda_a",
"quote": "treatment of adult patients with hypertension in combination with other antihypertensive drugs",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "molgramostim",
"p": "treats",
"t": "apap",
"src": "investors_default_aspx_2",
"quote": "in autoimmune pulmonary alveolar proteinosis",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "bezuclastinib",
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"t": "gist_sm",
"src": "investors_cogent_biosciences_announces_fda_accep",
"quote": "NDA for NonAdvanced Systemic Mastocytosis is under FDA review, and the NDA for GIST is also under FDA review",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "cagrisema",
"p": "treats",
"t": "obesity",
"src": "prnewswire_novo_nordisk_files_for_fda_approval_of",
"quote": "for weight management",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "zipalertinib",
"p": "treats",
"t": "ex20ins",
"src": "taihooncology_us_food_and_drug_administration_accept",
"quote": "NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "tinlarebant",
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"t": "stargardt",
"src": "investors_belite_bio_announces_us_food_and_drug",
"quote": "for the treatment of Stargardt Disease Type 1",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "lonvo_z",
"p": "treats",
"t": "hae",
"src": "ir_intellia_therapeutics_announces_fda_ac",
"quote": "for Hereditary Angioedema",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "bbp_418",
"p": "treats",
"t": "lgmd",
"src": "investor_default_aspx",
"quote": "for LGMD2I/R9",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "deucrictibant",
"p": "treats",
"t": "hae",
"src": "ir_pharvaris_announces_fda_acceptance_new",
"quote": "for on-demand treatment of hereditary angioedema attacks",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "icatibant",
"p": "treats",
"t": "hae",
"src": "pharvaris_about_pharvaris",
"quote": "icatibant for the treatment of HAE",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
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},
{
"s": "baxdrostat",
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"src": "astrazeneca_baxdrostat_mnr_2026_html",
"quote": "for adults with hypertension",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "deramiocel",
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"t": "dmd",
"src": "capricor_capricor_therapeutics_announces_extens",
"quote": "to treat Duchenne muscular dystrophy",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "baxdrostat",
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"t": "lorundrostat",
"src": "astrazeneca_baxdrostat_mnr_2026_html",
"quote": "the first and only aldosterone synthase inhibitor treatment for adults with hypertension",
"disc": "public",
"g": "prec",
"conf": 0.9,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "icatibant",
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"t": "deucrictibant",
"src": "sec_phvs_ex99_1_pdf",
"quote": "utilizes the same mechanism of action as icatibant with a distinctly different chemical structure",
"disc": "public",
"g": "prec",
"conf": 0.8,
"recorded_at": "2026-09-30",
"note": ""
},
{
"s": "phvs",
"p": "employs",
"t": "modig",
"src": "pharvaris_about_pharvaris",
"quote": "co-founded Pharvaris and has served as Chief Executive Officer since its inception",
"disc": "public",
"g": "team",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "phvs",
"p": "employs",
"t": "knolle",
"src": "moleculetomarket_a_billion_dollar_pipeline_in_a_pill",
"quote": "Jochen Knolle is now Pharvaris Chief Scientific Officer and Chief Operating Officer",
"disc": "public",
"g": "team",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "cgem",
"p": "employs",
"t": "ahmed",
"src": "biospace_cullinan_oncology_appoints_nadim_ahmed",
"quote": "Cullinan Oncology appoints Nadim Ahmed as Chief Executive Officer",
"disc": "public",
"g": "team",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "ntla",
"p": "employs",
"t": "leonard",
"src": "ir_intellia_therapeutics_names_john_leona",
"quote": "Intellia Therapeutics names John Leonard, M.D., President and Chief Executive Officer",
"disc": "public",
"g": "team",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "mlys",
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"t": "congleton",
"src": "mineralystx_about",
"quote": "has served as Chief Executive Officer and as a member of the Board since November 2020",
"disc": "public",
"g": "team",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "svra",
"p": "employs",
"t": "pauls",
"src": "savarapharma_matthew_pauls_chair_of_the_board_of_di",
"quote": "has served as Chair of the Board of Directors and Chief Executive Officer of Savara since 2020",
"disc": "public",
"g": "team",
"conf": 1.0,
"recorded_at": "2026-09-18",
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},
{
"s": "knolle",
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"t": "icatibant",
"src": "sec_phvs_ex99_1_pdf",
"quote": "is named as an author or inventor on numerous publications and patents, including for the approved therapeutics quinapril, a marketed ACE inhibitor, and icatibant",
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"g": "track",
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"note": ""
},
{
"s": "modig",
"p": "previously_shipped",
"t": "icatibant",
"src": "pharvaris_about_pharvaris",
"quote": "Chief Financial Officer at Jerini AG through its IPO on the Frankfurt exchange in 2005 and sale to Shire plc in 2008",
"disc": "public",
"g": "track",
"conf": 0.7,
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"note": ""
},
{
"s": "impala2",
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"src": "pubmed_40834301",
"quote": "estimated treatment difference of 6.0 percentage points (P < .001)",
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{
"s": "haelo",
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"src": "ir_intellia_therapeutics_reports_positive",
"quote": "met its primary and all key secondary endpoints",
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"g": "ev",
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"note": ""
},
{
"s": "launch_htn",
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"t": "lorundrostat",
"src": "ir_mineralys_therapeutics_announces_journ",
"quote": "sustained with a reduction of 19.0 mmHg at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001)",
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"g": "ev",
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"note": ""
},
{
"s": "rezilient1",
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"src": "onclive_fda_accepts_nda_for_zipalertinib_in_lo",
"quote": "confirmed ORR 35% (n=176) and mDOR 8.8 months at 100 mg BID",
"disc": "public",
"g": "ev",
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"recorded_at": "2026-09-18",
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},
{
"s": "rezilient3",
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"quote": "reduced the risk of disease progression by 50% compared to chemotherapy alone",
"disc": "public",
"g": "ev",
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"note": ""
},
{
"s": "rapide3",
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"t": "deucrictibant",
"src": "ir_pharvaris_announces_positive_topline_d",
"quote": "met its primary endpoint and all 11 secondary efficacy endpoints with statistical significance",
"disc": "public",
"g": "ev",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "dragon",
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"t": "tinlarebant",
"src": "investors_belite_bio_announces_us_food_and_drug",
"quote": "35.7% reduction in the growth rate of atrophic retinal lesions",
"disc": "public",
"g": "ev",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "ideate1",
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"t": "idxd",
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"quote": "objective response rate of 48.2% in previously treated extensive-stage small cell lung cancer",
"disc": "public",
"g": "ev",
"conf": 1.0,
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"note": ""
},
{
"s": "fortify",
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"quote": "BBP-418 demonstrates consistent efficacy and favorable safety profile in Phase 3 FORTIFY interim analysis",
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"g": "ev",
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"note": ""
},
{
"s": "hope3",
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"quote": "54% slowing of decline on PUL v2.0 (P = .029)",
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},
{
"s": "t_nct05208047",
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"quote": "(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors",
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"g": "ev",
"conf": 0.95,
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},
{
"s": "apex",
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"quote": "65% overall response rate based on mIWG-MRT-ECNM criteria, with 57% of patients achieving complete remission",
"disc": "public",
"g": "ev",
"conf": 1.0,
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},
{
"s": "ev_svra_rtf",
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"t": "molgramostim",
"src": "sec_d845572dex991_htm",
"quote": "today announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP",
"disc": "public",
"g": "reg",
"conf": 0.9,
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"note": ""
},
{
"s": "ev_svra_ext",
"p": "acted_on",
"t": "molgramostim",
"src": "investors_default_aspx_3",
"quote": "responses to recent information requests constituted a major amendment to the BLA",
"disc": "public",
"g": "reg",
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"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "ev_ntla_fetal",
"p": "acted_on",
"t": "lonvo_z",
"src": "fiercebiotech_intellia_germline_fda_request_gene_edi",
"quote": "the FDA asked the gene editing biotech for additional preclinical data on the inclusion of female patients of child-bearing potential",
"disc": "public",
"g": "reg",
"conf": 0.9,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "ev_ntla_adcom",
"p": "acted_on",
"t": "lonvo_z",
"src": "ir_intellia_therapeutics_announces_fda_ac",
"quote": "the FDA has advised the company that it is not currently planning to hold an advisory committee",
"disc": "public",
"g": "reg",
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"note": ""
},
{
"s": "ev_capr_crl",
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"t": "deramiocel",
"src": "download_crl_bla125842_20250709_pdf",
"quote": "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.",
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"g": "reg",
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},
{
"s": "ev_capr_ext",
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"t": "deramiocel",
"src": "capricor_capricor_therapeutics_announces_extens",
"quote": "extended the PDUFA target action date by three months",
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"g": "reg",
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"note": ""
},
{
"s": "ev_cogt_noiss",
"p": "acted_on",
"t": "bezuclastinib",
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"quote": "there is no plan to hold an advisory committee, nor have they identified any potential review issues",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "ev_phvs_acc",
"p": "acted_on",
"t": "deucrictibant",
"src": "ir_pharvaris_announces_fda_acceptance_new",
"quote": "FDA acceptance of New Drug Application for deucrictibant IR",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "phvs",
"p": "owns",
"t": "deucrictibant_xr",
"src": "ir_pharvaris_announces_positive_topline_d_2",
"quote": "Pharvaris announces positive topline data from CHAPTER-3 pivotal study of deucrictibant XR",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "deucrictibant_xr",
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"t": "hae",
"src": "ir_pharvaris_announces_positive_topline_d_2",
"quote": "for prophylaxis of HAE attacks",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "chapter3",
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"src": "ir_pharvaris_announces_positive_topline_d_2",
"quote": "reduced HAE attack rates by 83% versus placebo across all 3 HAE types",
"disc": "public",
"g": "ev",
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"note": ""
},
{
"s": "icatibant",
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"src": "sec_phvs_ex99_1_pdf",
"quote": "utilizes the same mechanism of action as icatibant with a distinctly different chemical structure",
"disc": "public",
"g": "prec",
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},
{
"s": "ev_cgem_deaths",
"p": "acted_on",
"t": "zipalertinib",
"src": "biospace_despite_3_patient_deaths_cullinan_taih",
"quote": "Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit",
"disc": "public",
"g": "reg",
"conf": 0.8,
"recorded_at": "2026-09-18",
"note": ""
},
{
"s": "tlx",
"p": "owns",
"t": "pixclara",
"src": "drugs_pixclara_html",
"quote": "Supplied by Telix Pharmaceuticals Limited",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "pixclara",
"p": "treats",
"t": "glioma",
"src": "drugs_pixclara_html",
"quote": "FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for Glioma",
"disc": "public",
"g": "ind",
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},
{
"s": "ev_tlx_appr",
"p": "acted_on",
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"quote": "FDA Approved: Yes (First approved September 11, 2026)",
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"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "rare",
"p": "owns",
"t": "fayuvi",
"src": "drugs_fayuvi_html",
"quote": "Supplied by Ultragenyx Pharmaceutical Inc.",
"disc": "public",
"g": "own",
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"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "fayuvi",
"p": "treats",
"t": "mps_iiia",
"src": "drugs_fayuvi_html",
"quote": "for the Treatment for Sanfilippo Syndrome Type A (MPS IIIA)",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "transpher_a",
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"src": "drugs_fayuvi_html",
"quote": "demonstrated a 23.5 point higher (p<0.0001) cognitive score over natural history during the period of study, providing the efficacy basis for standard full approval",
"disc": "public",
"g": "ev",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "ev_ux111_crl",
"p": "acted_on",
"t": "fayuvi",
"src": "download_crl_bla125845_20250707_pdf",
"quote": "Pursuant 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.",
"disc": "public",
"g": "reg",
"conf": 0.98,
"recorded_at": "2026-09-23",
"note": ""
},
{
"s": "ev_ux111_appr",
"p": "acted_on",
"t": "fayuvi",
"src": "drugs_fayuvi_html",
"quote": "FDA Approved: Yes (First approved September 17, 2026)",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "aclx",
"p": "owns",
"t": "anito_cel",
"src": "tipranks_arcellx_advances_anito_cel_as_fda_acce",
"quote": "The FDA accepted Arcellx's BLA for anito-cel on February 23, 2026, with a December 23, 2026 PDUFA date",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "anito_cel",
"p": "treats",
"t": "rrmm",
"src": "tipranks_arcellx_advances_anito_cel_as_fda_acce",
"quote": "for anito-cel as a fourth-line treatment for relapsed or refractory multiple myeloma",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "ev_capr_adcom",
"p": "acted_on",
"t": "deramiocel",
"src": "biopharmadive_826465",
"quote": "by a 9-3 vote, the advisory panel determined the results didn't show “substantial evidence” of the therapy's effectiveness",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "ev_ntla_acc",
"p": "acted_on",
"t": "lonvo_z",
"src": "ir_intellia_therapeutics_announces_fda_ac",
"quote": "FDA has accepted the BLA for lonvo-z and granted Priority Review",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "ev_idxd_acc",
"p": "acted_on",
"t": "idxd",
"src": "merck_ifinatamab_deruxtecan_granted_priority",
"quote": "Ifinatamab Deruxtecan Granted Priority Review in the U.S.",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "fda",
"p": "decides_on",
"t": "idxd",
"src": "merck_ifinatamab_deruxtecan_granted_priority",
"quote": "Ifinatamab Deruxtecan Granted Priority Review in the U.S.",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "vosoritide",
"src": "investors_default_aspx",
"quote": "BioMarin's supplemental New Drug Application for full approval of VOXZOGO",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "lorundrostat",
"src": "ir_mineralys_therapeutics_announces_fda_a",
"quote": "FDA acceptance of NDA for lorundrostat",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "molgramostim",
"src": "oindpnews_savara_resubmits_bla_for_molbreevi_mol",
"quote": "citing insufficient CMC data, the FDA issued a Refuse to File letter to the application in May 2025",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "bezuclastinib",
"src": "investors_cogent_biosciences_announces_fda_accep",
"quote": "there is no plan to hold an advisory committee, nor have they identified any potential review issues",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "cagrisema",
"src": "prnewswire_novo_nordisk_files_for_fda_approval_of",
"quote": "Novo Nordisk files for FDA approval of CagriSema",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "zipalertinib",
"src": "biospace_despite_3_patient_deaths_cullinan_taih",
"quote": "Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "tinlarebant",
"src": "investors_belite_bio_announces_us_food_and_drug",
"quote": "FDA has accepted and granted Priority Review designation of the NDA for tinlarebant",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "lonvo_z",
"src": "fiercebiotech_intellia_germline_fda_request_gene_edi",
"quote": "the FDA asked the gene editing biotech for additional preclinical data on the inclusion of female patients of child-bearing potential",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "bbp_418",
"src": "investor_default_aspx",
"quote": "FDA acceptance and priority review of NDA for BBP-418",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "deucrictibant",
"src": "ir_pharvaris_announces_fda_acceptance_new",
"quote": "FDA acceptance of New Drug Application for deucrictibant IR",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "deramiocel",
"src": "cgtlive_fda_extends_deramiocel_review_dmd",
"quote": "the file already drew a complete response letter",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "baxdrostat",
"src": "astrazeneca_baxdrostat_mnr_2026_html",
"quote": "Baxfendy approved in the US as the first and only aldosterone synthase inhibitor",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "icatibant",
"src": "pharvaris_about_pharvaris",
"quote": "Jerini developed and launched icatibant for the treatment of HAE",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "pixclara",
"src": "drugs_pixclara_html",
"quote": "FDA Approved: Yes (First approved September 11, 2026)",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "fayuvi",
"src": "drugs_fayuvi_html",
"quote": "Jul 11, 2025 Ultragenyx Receives Complete Response Letter from FDA for UX111",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "fda",
"p": "decides_on",
"t": "anito_cel",
"src": "tipranks_arcellx_advances_anito_cel_as_fda_acce",
"quote": "The FDA accepted Arcellx's BLA for anito-cel on February 23, 2026, with a December 23, 2026 PDUFA date",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing. Sourced to the same release that establishes the action for this drug."
},
{
"s": "lly",
"p": "owns",
"t": "orforglipron",
"src": "drugs_foundayo_html",
"quote": "Supplied by Eli Lilly and Company",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "orforglipron",
"p": "treats",
"t": "obesity",
"src": "drugs_foundayo_html",
"quote": "Supplied by Eli Lilly and Company",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Indication taken from the same approval history page."
},
{
"s": "ev_orforgli_appr",
"p": "acted_on",
"t": "orforglipron",
"src": "drugs_foundayo_html",
"quote": "First approved April 1, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "fda",
"p": "decides_on",
"t": "orforglipron",
"src": "drugs_foundayo_html",
"quote": "First approved April 1, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing."
},
{
"s": "tak",
"p": "owns",
"t": "oveporexton",
"src": "drugs_orzeyful_html",
"quote": "Supplied by Takeda Pharmaceutical Company Limited",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "oveporexton",
"p": "treats",
"t": "narcolepsy",
"src": "drugs_orzeyful_html",
"quote": "Supplied by Takeda Pharmaceutical Company Limited",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Indication taken from the same approval history page."
},
{
"s": "ev_oveporex_appr",
"p": "acted_on",
"t": "oveporexton",
"src": "drugs_orzeyful_html",
"quote": "First approved August 5, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "fda",
"p": "decides_on",
"t": "oveporexton",
"src": "drugs_orzeyful_html",
"quote": "First approved August 5, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing."
},
{
"s": "ptgx",
"p": "owns",
"t": "rusfertide",
"src": "drugs_mimrylo_html",
"quote": "Supplied by Takeda and Protagonist Therapeutics",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "rusfertide",
"p": "treats",
"t": "pv",
"src": "drugs_mimrylo_html",
"quote": "Supplied by Takeda and Protagonist Therapeutics",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Indication taken from the same approval history page."
},
{
"s": "ev_rusferti_appr",
"p": "acted_on",
"t": "rusfertide",
"src": "drugs_mimrylo_html",
"quote": "First approved August 28, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "fda",
"p": "decides_on",
"t": "rusfertide",
"src": "drugs_mimrylo_html",
"quote": "First approved August 28, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing."
},
{
"s": "srrk",
"p": "owns",
"t": "apitegromab",
"src": "drugs_isembyld_html",
"quote": "Supplied by Scholar Rock",
"disc": "public",
"g": "own",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "apitegromab",
"p": "treats",
"t": "sma",
"src": "drugs_isembyld_html",
"quote": "Supplied by Scholar Rock",
"disc": "public",
"g": "ind",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Indication taken from the same approval history page."
},
{
"s": "ev_apitegro_appr",
"p": "acted_on",
"t": "apitegromab",
"src": "drugs_isembyld_html",
"quote": "First approved September 11, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "fda",
"p": "decides_on",
"t": "apitegromab",
"src": "drugs_isembyld_html",
"quote": "First approved September 11, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": "Structural. The FDA holds the decision on this filing."
},
{
"s": "ev_baxdrostat_appr",
"p": "acted_on",
"t": "baxdrostat",
"src": "drugs_baxfendy_html",
"quote": "First approved May 15, 2026",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "ev_icatibant_appr",
"p": "acted_on",
"t": "icatibant",
"src": "drugs_firazyr_html",
"quote": "First approved August 25, 2011",
"disc": "public",
"g": "reg",
"conf": 1.0,
"recorded_at": "2026-09-22",
"note": ""
},
{
"s": "ev_srrk_crl",
"p": "acted_on",
"t": "apitegromab",
"src": "download_crl_bla761463_20250922_pdf",
"quote": "The deficiencies identified during the inspection may not be specific to your application.",
"disc": "public",
"g": "reg",
"conf": 0.98,
"recorded_at": "2026-09-23",
"note": ""
},
{
"s": "ev_tlx_crl",
"p": "acted_on",
"t": "pixclara",
"src": "download_crl_nda218592_20250425_pdf",
"quote": "The clinical data submitted in this application did not provide substantial evidence of effectiveness for floretyrosine F 18.",
"disc": "public",
"g": "reg",
"conf": 0.98,
"recorded_at": "2026-09-23",
"note": ""
},
{
"s": "rare",
"p": "employs",
"t": "p_sec_0001206199",
"src": "sec_browse_edgar_action_getcompany_cik_000",
"quote": "true",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "srrk",
"p": "employs",
"t": "p_sec_0001569248",
"src": "sec_browse_edgar_action_getcompany_cik_000_2",
"quote": "true",
"disc": "public",
"g": "people",
"conf": 0.97,
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"note": ""
},
{
"s": "rare",
"p": "employs",
"t": "p_sec_0001397266",
"src": "sec_browse_edgar_action_getcompany_cik_000_3",
"quote": "true",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "mlys",
"p": "employs",
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"quote": "1",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "srrk",
"p": "employs",
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"src": "sec_browse_edgar_action_getcompany_cik_000_4",
"quote": "1",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "rare",
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"src": "sec_browse_edgar_action_getcompany_cik_000_5",
"quote": "true",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "srrk",
"p": "employs",
"t": "p_sec_0001692359",
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"quote": "1",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "rare",
"p": "employs",
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"quote": "true",
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"note": ""
},
{
"s": "capr",
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"quote": "true",
"disc": "public",
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"note": ""
},
{
"s": "srrk",
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"quote": "Chief Executive Officer",
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"g": "people",
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},
{
"s": "rare",
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"t": "p_sec_0001677455",
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"quote": "EVP and Chief Legal Officer",
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"note": ""
},
{
"s": "srrk",
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"quote": "Chief Financial Officer",
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"note": ""
},
{
"s": "srrk",
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"quote": "President of R&D",
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"note": ""
},
{
"s": "rare",
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"quote": "EVP & Chief Commercial Officer",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "srrk",
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"quote": "true",
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"note": ""
},
{
"s": "srrk",
"p": "employs",
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"quote": "Chief Operating Officer",
"disc": "public",
"g": "people",
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"note": ""
},
{
"s": "rare",
"p": "employs",
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"quote": "true",
"disc": "public",
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"note": ""
},
{
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"title": "sec.gov, on Rhonda Janice Pacheco",
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"title": "sec.gov, on Andrew R Allen",
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"title": "sec.gov, on Arlene Morris",
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"title": "sec.gov, on Athena Countouriotis",
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"title": "sec.gov, on Barbara W. Bodem",
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"title": "sec.gov, on Charles J Homcy",
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"title": "sec.gov, on Eric Aguiar",
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"title": "sec.gov, on Fred E Cohen",
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"title": "sec.gov, on Fred Hassan",
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"title": "sec.gov, on Mary Thistle",
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"title": "sec.gov, on Pamela J. Craig",
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"title": "sec.gov, on Peter Evan Harwin",
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"title": "sec.gov, on Robert J. Hombach",
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"title": "sec.gov, on Stephen W Webster",
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"title": "sec.gov, on Timothy P Walbert",
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"title": "sec.gov, on Andrew Lo",
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"title": "sec.gov, on David D. Meek",
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"title": "sec.gov, on Glenn Sblendorio",
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"title": "sec.gov, on James C Momtazee",
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"title": "sec.gov, on Mark J Enyedy",
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"title": "sec.gov, on Risa J Lavizzo-mourey",
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"title": "sec.gov, on Willard H Dere",
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"title": "sec.gov, on Derek DiRocco",
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"title": "sec.gov, on Richard A Meier",
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"title": "sec.gov, on Betty D Larson",
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"title": "sec.gov, on Brian Goff",
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"title": "sec.gov, on Daphne Karydas",
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"title": "sec.gov, on Frank Mccormick",
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"title": "sec.gov, on John M Leonard",
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"title": "sec.gov, on Karen Jean Ferrante",
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"title": "sec.gov, on Maykin Ho",
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"title": "sec.gov, on Patricia F Russo",
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"title": "sec.gov, on Randal W. Scott",
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"title": "sec.gov, on Ali J. Satvat",
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"title": "sec.gov, on Andrew R Robbins",
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"title": "sec.gov, on Christopher W. Cain",
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"title": "sec.gov, on Inge G Thulin",
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"title": "sec.gov, on Douglas M Baker JR",
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"title": "sec.gov, on Georgia Keresty",
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"title": "sec.gov, on James J. Ferguson III",
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"title": "sec.gov, on Jennifer E. Cook",
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"title": "sec.gov, on Matthew Ros",
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"title": "sec.gov, on Mittie Doyle",
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"title": "sec.gov, on Paul Rothman",
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"title": "sec.gov, on Robert M Plenge",
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"title": "sec.gov, on Stephen Mayo",
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"title": "sec.gov, on Thomas H Glocer",
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"title": "sec.gov, on Dean Y Li",
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"title": "sec.gov, on Edward J Dulac III",
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"title": "sec.gov, on Elaine J Heron",
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"title": "sec.gov, on Elisabeth Bjork",
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"title": "sec.gov, on Eric Warren",
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"title": "sec.gov, on Evan Kearns",
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"title": "sec.gov, on Jacquelyn L Sumer",
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"title": "sec.gov, on Jennifer Zachary",
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"title": "sec.gov, on Jesse Goodman",
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"title": "sec.gov, on John L. Green",
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"title": "sec.gov, on Kathy J Warden",
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"title": "sec.gov, on Mary Ellen Coe",
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"title": "sec.gov, on Richard R. DeLuca",
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"title": "sec.gov, on Sanat Chattopadhyay",
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"title": "sec.gov, on Surendralal Lanca Karsanbhai",
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"title": "sec.gov, on Alexander Hardy",
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"title": "sec.gov, on Alexander M Gold",
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"title": "sec.gov, on Andrea Ellis",
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"title": "sec.gov, on Anna Nijdam",
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"title": "sec.gov, on Anne Lesage",
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"title": "sec.gov, on Anne-Marie Martin",
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"title": "sec.gov, on Birgit C Schultes",
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"title": "sec.gov, on Brian Foard",
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"title": "sec.gov, on Brian Taylor Slingsby",
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"title": "sec.gov, on Charles Greg Guyer",
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"title": "sec.gov, on Christine E Seidman",
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"title": "sec.gov, on Cole Pinnow",
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"title": "sec.gov, on Corrine Savill",
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"title": "sec.gov, on Cristin Hubbard",
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"title": "sec.gov, on Dalton E. Smart III",
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"title": "sec.gov, on Hendrik Peter Scholl",
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"title": "sec.gov, on Jennifer Michaelson",
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"title": "sec.gov, on Johannes Gerardus Christiaan Petrus Schikan",
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"title": "sec.gov, on John Michael Longo",
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"title": "sec.gov, on Michael P Dube",
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"title": "sec.gov, on Nathan L. Mata",
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"title": "sec.gov, on Robert Glassman",
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"title": "sec.gov, on Thomas Trimarchi",
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"title": "sec.gov, on Wan-Shan Chen",
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"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_browse_edgar_action_getcompany_cik_000_262": {
"title": "sec.gov, on Wim Souverijns",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001973529&type=4",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_browse_edgar_action_getcompany_cik_000_263": {
"title": "sec.gov, on Xiao-Hui Chen",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0002106182&type=4",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_browse_edgar_action_getcompany_cik_000_264": {
"title": "sec.gov, on Yasmine Wasfi",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0002092127&type=4",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_browse_edgar_action_getcompany_cik_000_265": {
"title": "sec.gov, on Yu-Hsin Lin",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001965964&type=4",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"clinicaltrials_nct04544293": {
"title": "clinicaltrials.gov, NCT04544293, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT04544293",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 164, primary completion 2023-11-30. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct04036682": {
"title": "clinicaltrials.gov, NCT04036682, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT04036682",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 284, primary completion 2025-10-13. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05126758": {
"title": "clinicaltrials.gov, NCT05126758, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05126758",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 106, primary completion 2025-06-18. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct04996875": {
"title": "clinicaltrials.gov, NCT04996875, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT04996875",
"kind": "public",
"note": "Status RECRUITING, enrolment 140, primary completion 2025-09-19. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05156320": {
"title": "clinicaltrials.gov, NCT05156320, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05156320",
"kind": "public",
"note": "Status COMPLETED, enrolment 188, primary completion 2024-12-18. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05626855": {
"title": "clinicaltrials.gov, NCT05626855, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05626855",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 238, primary completion 2026-11-01. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06034743": {
"title": "clinicaltrials.gov, NCT06034743, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06034743",
"kind": "public",
"note": "Status COMPLETED, enrolment 796, primary completion 2025-05-21. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06168409": {
"title": "clinicaltrials.gov, NCT06168409, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06168409",
"kind": "public",
"note": "Status COMPLETED, enrolment 218, primary completion 2025-08-17. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06268873": {
"title": "clinicaltrials.gov, NCT06268873, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06268873",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 2554, primary completion 2028-02-24. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06344104": {
"title": "clinicaltrials.gov, NCT06344104, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06344104",
"kind": "public",
"note": "Status COMPLETED, enrolment 326, primary completion 2025-11-24. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06677060": {
"title": "clinicaltrials.gov, NCT06677060, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06677060",
"kind": "public",
"note": "Status RECRUITING, enrolment 11300, primary completion 2029-12-17. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06742723": {
"title": "clinicaltrials.gov, NCT06742723, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06742723",
"kind": "public",
"note": "Status RECRUITING, enrolment 5000, primary completion 2029-12-18. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07007793": {
"title": "clinicaltrials.gov, NCT07007793, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07007793",
"kind": "public",
"note": "Status RECRUITING, enrolment 250, primary completion 2027-08-13. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07655362": {
"title": "clinicaltrials.gov, NCT07655362, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07655362",
"kind": "public",
"note": "Status NOT_YET_RECRUITING, enrolment 286, primary completion 2028-06-30. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07686120": {
"title": "clinicaltrials.gov, NCT07686120, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07686120",
"kind": "public",
"note": "Status NOT_YET_RECRUITING, enrolment 286, primary completion 2028-02-09. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct00997204": {
"title": "clinicaltrials.gov, NCT00997204, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT00997204",
"kind": "public",
"note": "Status COMPLETED, enrolment 151, primary completion 2011-06-22. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05869903": {
"title": "clinicaltrials.gov, NCT05869903, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05869903",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 3127, primary completion 2025-07-25. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05931380": {
"title": "clinicaltrials.gov, NCT05931380, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05931380",
"kind": "public",
"note": "Status COMPLETED, enrolment 238, primary completion 2025-06-19. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06010004": {
"title": "clinicaltrials.gov, NCT06010004, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06010004",
"kind": "public",
"note": "Status COMPLETED, enrolment 401, primary completion 2025-06-05. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06045221": {
"title": "clinicaltrials.gov, NCT06045221, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06045221",
"kind": "public",
"note": "Status COMPLETED, enrolment 1698, primary completion 2025-08-22. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06109311": {
"title": "clinicaltrials.gov, NCT06109311, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06109311",
"kind": "public",
"note": "Status COMPLETED, enrolment 546, primary completion 2025-09-15. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06192108": {
"title": "clinicaltrials.gov, NCT06192108, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06192108",
"kind": "public",
"note": "Status COMPLETED, enrolment 962, primary completion 2025-09-26. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06649045": {
"title": "clinicaltrials.gov, NCT06649045, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06649045",
"kind": "public",
"note": "Status COMPLETED, enrolment 712, primary completion 2026-07-21. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06672549": {
"title": "clinicaltrials.gov, NCT06672549, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06672549",
"kind": "public",
"note": "Status RECRUITING, enrolment 125, primary completion 2027-02. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06948422": {
"title": "clinicaltrials.gov, NCT06948422, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06948422",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 974, primary completion 2027-09. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06948435": {
"title": "clinicaltrials.gov, NCT06948435, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06948435",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 487, primary completion 2027-09. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06972459": {
"title": "clinicaltrials.gov, NCT06972459, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06972459",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 800, primary completion 2027-08. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06972472": {
"title": "clinicaltrials.gov, NCT06972472, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06972472",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 600, primary completion 2027-08. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07153471": {
"title": "clinicaltrials.gov, NCT07153471, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07153471",
"kind": "public",
"note": "Status RECRUITING, enrolment 800, primary completion 2028-04. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07202884": {
"title": "clinicaltrials.gov, NCT07202884, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07202884",
"kind": "public",
"note": "Status RECRUITING, enrolment 1000, primary completion 2028-03. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07223593": {
"title": "clinicaltrials.gov, NCT07223593, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07223593",
"kind": "public",
"note": "Status RECRUITING, enrolment 1205, primary completion 2028-06. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07668336": {
"title": "clinicaltrials.gov, NCT07668336, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07668336",
"kind": "public",
"note": "Status NOT_YET_RECRUITING, enrolment 170, primary completion 2030-03. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07790861": {
"title": "clinicaltrials.gov, NCT07790861, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07790861",
"kind": "public",
"note": "Status NOT_YET_RECRUITING, enrolment 192, primary completion 2028-03. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07794579": {
"title": "clinicaltrials.gov, NCT07794579, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07794579",
"kind": "public",
"note": "Status RECRUITING, enrolment 2001, primary completion 2029-08. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06470828": {
"title": "clinicaltrials.gov, NCT06470828, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06470828",
"kind": "public",
"note": "Status COMPLETED, enrolment 168, primary completion 2025-06-03. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06505031": {
"title": "clinicaltrials.gov, NCT06505031, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06505031",
"kind": "public",
"note": "Status COMPLETED, enrolment 105, primary completion 2025-06-04. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07363720": {
"title": "clinicaltrials.gov, NCT07363720, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07363720",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 98, primary completion 2026-10-02. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06413498": {
"title": "clinicaltrials.gov, NCT06413498, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06413498",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 452, primary completion 2028-07. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05394519": {
"title": "clinicaltrials.gov, NCT05394519, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05394519",
"kind": "public",
"note": "Status COMPLETED, enrolment 1200, primary completion 2025-01-28. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05567796": {
"title": "clinicaltrials.gov, NCT05567796, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05567796",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 3400, primary completion 2024-10-30. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05669755": {
"title": "clinicaltrials.gov, NCT05669755, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05669755",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 7101, primary completion 2027-09-01. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05813925": {
"title": "clinicaltrials.gov, NCT05813925, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05813925",
"kind": "public",
"note": "Status COMPLETED, enrolment 331, primary completion 2025-01-17. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05996848": {
"title": "clinicaltrials.gov, NCT05996848, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05996848",
"kind": "public",
"note": "Status COMPLETED, enrolment 300, primary completion 2025-01-06. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06065540": {
"title": "clinicaltrials.gov, NCT06065540, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06065540",
"kind": "public",
"note": "Status COMPLETED, enrolment 2734, primary completion 2025-11-19. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06131437": {
"title": "clinicaltrials.gov, NCT06131437, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06131437",
"kind": "public",
"note": "Status COMPLETED, enrolment 809, primary completion 2025-12-08. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06221969": {
"title": "clinicaltrials.gov, NCT06221969, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06221969",
"kind": "public",
"note": "Status COMPLETED, enrolment 1024, primary completion 2026-03-04. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06323161": {
"title": "clinicaltrials.gov, NCT06323161, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06323161",
"kind": "public",
"note": "Status COMPLETED, enrolment 274, primary completion 2025-09-09. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06323174": {
"title": "clinicaltrials.gov, NCT06323174, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06323174",
"kind": "public",
"note": "Status COMPLETED, enrolment 189, primary completion 2025-10-01. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06388187": {
"title": "clinicaltrials.gov, NCT06388187, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06388187",
"kind": "public",
"note": "Status COMPLETED, enrolment 300, primary completion 2026-04-22. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06534411": {
"title": "clinicaltrials.gov, NCT06534411, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06534411",
"kind": "public",
"note": "Status COMPLETED, enrolment 1023, primary completion 2026-06-02. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06780449": {
"title": "clinicaltrials.gov, NCT06780449, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06780449",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 400, primary completion 2028-08-28. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07011667": {
"title": "clinicaltrials.gov, NCT07011667, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07011667",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 609, primary completion 2027-03-01. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07253285": {
"title": "clinicaltrials.gov, NCT07253285, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07253285",
"kind": "public",
"note": "Status RECRUITING, enrolment 460, primary completion 2030-03-20. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07282613": {
"title": "clinicaltrials.gov, NCT07282613, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07282613",
"kind": "public",
"note": "Status RECRUITING, enrolment 80, primary completion 2029-09-07. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07357766": {
"title": "clinicaltrials.gov, NCT07357766, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07357766",
"kind": "public",
"note": "Status WITHDRAWN, enrolment 0, primary completion 2027-11-29. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07564414": {
"title": "clinicaltrials.gov, NCT07564414, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07564414",
"kind": "public",
"note": "Status RECRUITING, enrolment 2500, primary completion 2028-02-23. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07817251": {
"title": "clinicaltrials.gov, NCT07817251, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07817251",
"kind": "public",
"note": "Status NOT_YET_RECRUITING, enrolment 210, primary completion 2027-06-09. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06679881": {
"title": "clinicaltrials.gov, NCT06679881, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06679881",
"kind": "public",
"note": "Status ENROLLING_BY_INVITATION, enrolment 170, primary completion 2028-12. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct07266805": {
"title": "clinicaltrials.gov, NCT07266805, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT07266805",
"kind": "public",
"note": "Status RECRUITING, enrolment 48, primary completion 2027-06. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06203210": {
"title": "clinicaltrials.gov, NCT06203210, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06203210",
"kind": "public",
"note": "Status RECRUITING, enrolment 540, primary completion 2028-01-30. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06644781": {
"title": "clinicaltrials.gov, NCT06644781, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06644781",
"kind": "public",
"note": "Status RECRUITING, enrolment 510, primary completion 2028-06-01. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06925737": {
"title": "clinicaltrials.gov, NCT06925737, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06925737",
"kind": "public",
"note": "Status RECRUITING, enrolment 1440, primary completion 2028-06-26. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05949593": {
"title": "clinicaltrials.gov, NCT05949593, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05949593",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 429, primary completion 2027-06-30. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct03197766": {
"title": "clinicaltrials.gov, NCT03197766, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT03197766",
"kind": "public",
"note": "Status COMPLETED, enrolment 121, primary completion 2019-10-30. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06455059": {
"title": "clinicaltrials.gov, NCT06455059, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06455059",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 80, primary completion 2026-08-01. Tied to this trial on name and drug named in title and sponsor.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"drugs_bezuclastinib_260528_html": {
"title": "drugs.com, on Bezuclastinib",
"url": "https://www.drugs.com/nda/bezuclastinib_260528.html",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"merck_ifinatamab_deruxtecan_biologics_licens": {
"title": "merck.com, on Ifinatamab deruxtecan",
"url": "https://www.merck.com/news/ifinatamab-deruxtecan-biologics-license-application-for-certain-patients-with-previously-treated-extensive-stage-small-cell-lung-cancer-voluntarily-withdrawn/",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_cogt_20260630_htm": {
"title": "sec.gov, on Bezuclastinib (NonAdvSM), Nonadvanced systemic mastocytosis",
"url": "https://www.sec.gov/Archives/edgar/data/1622229/000119312526342393/cogt-20260630.htm",
"kind": "public",
"note": "4 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"globenewswire_cogent_biosciences_announces_fda_accep": {
"title": "globenewswire.com, on Bezuclastinib (NonAdvSM)",
"url": "https://www.globenewswire.com/news-release/2026/03/16/3256200/0/en/cogent-biosciences-announces-fda-acceptance-of-new-drug-application-for-bezuclastinib-in-patients-with-nonadvanced-systemic-mastocytosis-nonadvsm.html",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"globenewswire_cogent_biosciences_announces_fda_accep_2": {
"title": "globenewswire.com, on Advanced systemic mastocytosis, Bezuclastinib (AdvSM)",
"url": "https://www.globenewswire.com/news-release/2026/09/15/3361988/0/en/cogent-biosciences-announces-fda-acceptance-of-new-drug-application-nda-for-bezuclastinib-in-patients-with-advanced-systemic-mastocytosis-advsm.html",
"kind": "public",
"note": "5 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_cgem_ex99_1_htm": {
"title": "sec.gov, on Zipalertinib + chemotherapy (first line)",
"url": "https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-ex99_1.htm",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"sec_ef20074977_ex99_1_htm": {
"title": "sec.gov, on BBP-418",
"url": "https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/ef20074977_ex99-1.htm",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"investors_default_aspx_4": {
"title": "investors.savarapharma.com, on Molgramostim",
"url": "https://investors.savarapharma.com/news/news-details/2026/Savara-Provides-Regulatory-Update-on-the-MOLBREEVI-Development-Program-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx",
"kind": "public",
"note": "1 claim(s) in this record rest on this address.",
"checked": "2026-10-05"
},
"avalere_crl_base_rate": {
"title": "advisory.avalerehealth.com, on the FDA complete response letter base rate",
"url": "https://advisory.avalerehealth.com/insights/what-is-a-complete-response-letter",
"kind": "public",
"note": "The cohort base rate behind the Odds and Upside view: 37 percent of BLAs and NDAs took a complete response letter in the 2018 to 2022 PDUFA cycle.",
"checked": "2026-10-05",
"cited_by": "the Odds and Upside view"
},
"openfda_complete_response_letters": {
"title": "open.fda.gov, the FDA's Complete Response Letter database",
"url": "https://open.fda.gov/apis/transparency/completeresponseletters/",
"kind": "public",
"note": "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.",
"checked": "2026-09-23",
"cited_by": "the FDA's Own Words view"
},
"clinicaltrials_nct06634420": {
"title": "clinicaltrials.gov, NCT06634420, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06634420",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 80, primary completion 2026-02-10. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06153693": {
"title": "clinicaltrials.gov, NCT06153693, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06153693",
"kind": "public",
"note": "Status COMPLETED, enrolment 1083, primary completion 2024-12-10. Tied to this trial on sponsor and drug named in title and enrolment.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05973773": {
"title": "clinicaltrials.gov, NCT05973773, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05973773",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 285, primary completion 2027-05-27. Tied to this trial on name and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06343779": {
"title": "clinicaltrials.gov, NCT06343779, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06343779",
"kind": "public",
"note": "Status COMPLETED, enrolment 134, primary completion 2025-10-17. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05244304": {
"title": "clinicaltrials.gov, NCT05244304, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05244304",
"kind": "public",
"note": "Status COMPLETED, enrolment 104, primary completion 2025-08-04. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05280470": {
"title": "clinicaltrials.gov, NCT05280470, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05280470",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 187, primary completion 2025-03-03. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct05775848": {
"title": "clinicaltrials.gov, NCT05775848, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT05775848",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 112, primary completion 2027-09. Tied to this trial on name and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"clinicaltrials_nct06669754": {
"title": "clinicaltrials.gov, NCT06669754, a registration behind this board",
"url": "https://clinicaltrials.gov/study/NCT06669754",
"kind": "public",
"note": "Status ACTIVE_NOT_RECRUITING, enrolment 81, primary completion 2026-08. Tied to this trial on name and sponsor and drug named in title.",
"checked": "2026-09-23",
"cited_by": "the Registrational Trials view"
},
"cboe_bmrn": {
"title": "Cboe delayed options quotes, BMRN",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/BMRN.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-03 23:17:49.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_mlys": {
"title": "Cboe delayed options quotes, MLYS",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/MLYS.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-04 23:26:59.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_svra": {
"title": "Cboe delayed options quotes, SVRA",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/SVRA.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-03 23:31:10.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_cogt": {
"title": "Cboe delayed options quotes, COGT",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/COGT.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-03 23:27:30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_nvo": {
"title": "Cboe delayed options quotes, NVO",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/NVO.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-04 01:00:49.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_cgem": {
"title": "Cboe delayed options quotes, CGEM",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/CGEM.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-04 00:01:51.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_ntla": {
"title": "Cboe delayed options quotes, NTLA",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/NTLA.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-04 23:55:26.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_bbio": {
"title": "Cboe delayed options quotes, BBIO",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/BBIO.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-02 23:25:29.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_phvs": {
"title": "Cboe delayed options quotes, PHVS",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/PHVS.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-03 23:46:00.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"cboe_capr": {
"title": "Cboe delayed options quotes, CAPR",
"url": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/CAPR.json",
"kind": "public",
"note": "At-the-money straddles either side of the decision, quote time 2026-10-03 23:22:44.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_mlys": {
"title": "SEC XBRL company facts, MLYS",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001933414.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_phvs": {
"title": "SEC XBRL company facts, PHVS",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001830487.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2025-12-31.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_cogt": {
"title": "SEC XBRL company facts, COGT",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001622229.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_bbio": {
"title": "SEC XBRL company facts, BBIO",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001743881.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_bmrn": {
"title": "SEC XBRL company facts, BMRN",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001048477.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_blte": {
"title": "SEC XBRL company facts, BLTE",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001889109.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2025-12-31.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_cgem": {
"title": "SEC XBRL company facts, CGEM",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001789972.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_svra": {
"title": "SEC XBRL company facts, SVRA",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001160308.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_ntla": {
"title": "SEC XBRL company facts, NTLA",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001652130.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_xbrl_capr": {
"title": "SEC XBRL company facts, CAPR",
"url": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001133869.json",
"kind": "public",
"note": "Cash, investments, debt and operating cash flow as filed, period ending 2026-06-30.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000193341426000121": {
"title": "SEC Form 4, MLYS, Congleton Jon",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000193341426000121/wk-form4_1790978009.xml",
"kind": "public",
"note": "Filed 2026-10-02.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000196390126000003": {
"title": "SEC Form 4, MLYS, Slingsby Brian Taylor",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000196390126000003/wk-form4_1790300978.xml",
"kind": "public",
"note": "Filed 2026-09-24.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000191604826000014": {
"title": "SEC Form 4, MLYS, Warren Eric",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000191604826000014/wk-form4_1790117313.xml",
"kind": "public",
"note": "Filed 2026-09-22.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000181695226000005": {
"title": "SEC Form 4, MLYS, Karydas Daphne",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000181695226000005/wk-form4_1789681270.xml",
"kind": "public",
"note": "Filed 2026-09-17.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000191604826000012": {
"title": "SEC Form 4, MLYS, Warren Eric",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000191604826000012/wk-form4_1787692603.xml",
"kind": "public",
"note": "Filed 2026-08-25.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000193341426000118": {
"title": "SEC Form 4, MLYS, Rodman David Malcom",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000193341426000118/wk-form4_1786577585.xml",
"kind": "public",
"note": "Filed 2026-08-12.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000191604826000009": {
"title": "SEC Form 4, MLYS, Warren Eric",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000191604826000009/wk-form4_1784846362.xml",
"kind": "public",
"note": "Filed 2026-07-23.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000167265926000036": {
"title": "SEC Form 4, MLYS, Rodman David Malcom",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000167265926000036/wk-form4_1784595624.xml",
"kind": "public",
"note": "Filed 2026-07-20.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000193341426000100": {
"title": "SEC Form 4, MLYS, Congleton Jon",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000193341426000100/wk-form4_1784163491.xml",
"kind": "public",
"note": "Filed 2026-07-15.",
"checked": "2026-10-05",
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},
"form4_000193341426000099": {
"title": "SEC Form 4, MLYS, Rodman David Malcom",
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"kind": "public",
"note": "Filed 2026-07-15.",
"checked": "2026-10-05",
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},
"form4_000167265926000033": {
"title": "SEC Form 4, MLYS, Rodman David Malcom",
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"note": "Filed 2026-07-10.",
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},
"form4_000119312526402567": {
"title": "SEC Form 4, PHVS, Monges Viviane",
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"kind": "public",
"note": "Filed 2026-09-25.",
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},
"form4_000119312526400435": {
"title": "SEC Form 4, PHVS, Schikan Johannes Gerardus Christiaan Petrus",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526400435/ownership.xml",
"kind": "public",
"note": "Filed 2026-09-24.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526398678": {
"title": "SEC Form 4, PHVS, Nassif David W.",
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"note": "Filed 2026-09-23.",
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"form4_000119312526396695": {
"title": "SEC Form 4, PHVS, Lu Peng",
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"note": "Filed 2026-09-21.",
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"form4_000119312526396689": {
"title": "SEC Form 4, PHVS, Schikan Johannes Gerardus Christiaan Petrus",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526396689/ownership.xml",
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"note": "Filed 2026-09-21.",
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"form4_000119312526396584": {
"title": "SEC Form 4, PHVS, Bjork Elisabeth",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526396584/ownership.xml",
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"note": "Filed 2026-09-21.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526396579": {
"title": "SEC Form 4, PHVS, Glassman Robert",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526396579/ownership.xml",
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"note": "Filed 2026-09-21.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, PHVS, Lesage Anne",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526396572/ownership.xml",
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"note": "Filed 2026-09-21.",
"checked": "2026-10-05",
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"form4_000119312526394103": {
"title": "SEC Form 4, PHVS, Abele Stefan Andreas",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526394103/ownership.xml",
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"note": "Filed 2026-09-17.",
"checked": "2026-10-05",
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"form4_000119312526393860": {
"title": "SEC Form 4, PHVS, Glassman Robert",
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"note": "Filed 2026-09-17.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526392895": {
"title": "SEC Form 4, PHVS, Souverijns Wim",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526392895/ownership.xml",
"kind": "public",
"note": "Filed 2026-09-16.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"form4_000119312526391740": {
"title": "SEC Form 4, PHVS, Lu Peng",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526391740/ownership.xml",
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"note": "Filed 2026-09-15.",
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"cited_by": "the What the Market Prices view"
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"form4_000119312526391713": {
"title": "SEC Form 4, PHVS, Modig Berndt",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526391713/ownership.xml",
"kind": "public",
"note": "Filed 2026-09-15.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526390119": {
"title": "SEC Form 4, PHVS, Lesage Anne",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526390119/ownership.xml",
"kind": "public",
"note": "Filed 2026-09-14.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526388909": {
"title": "SEC Form 4, PHVS, Glassman Robert",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526388909/ownership.xml",
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"note": "Filed 2026-09-11.",
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"cited_by": "the What the Market Prices view"
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"form4_000119312526386096": {
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"note": "Filed 2026-09-09.",
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"note": "Filed 2026-08-18.",
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"form4_000119312526304445": {
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"note": "Filed 2026-07-15.",
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"title": "SEC Form 4, PHVS, Modig Berndt",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526396565/ownership.xml",
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"note": "Filed as code M.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526377001": {
"title": "SEC Form 4, COGT, Morris Arlene",
"url": "https://www.sec.gov/Archives/edgar/data/1622229/000119312526377001/ownership.xml",
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"note": "Filed 2026-08-31.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"note": "Filed 2026-09-21.",
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"note": "Filed 2026-08-20.",
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"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, BBIO, Apuli Maricel",
"url": "https://www.sec.gov/Archives/edgar/data/1743881/000147083126000745/wk-form4_1785788451.xml",
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"note": "Filed 2026-08-03.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000147083126000709": {
"title": "SEC Form 4, BBIO, Ellis Andrea",
"url": "https://www.sec.gov/Archives/edgar/data/1743881/000147083126000709/wk-form4_1783975290.xml",
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"note": "Filed 2026-07-13.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000147083126000708": {
"title": "SEC Form 4, BBIO, Cook Jennifer E.",
"url": "https://www.sec.gov/Archives/edgar/data/1743881/000147083126000708/wk-form4_1783975232.xml",
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"note": "Filed 2026-07-13.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000162828026060572": {
"title": "SEC Form 4, BMRN, Davis George Eric",
"url": "https://www.sec.gov/Archives/edgar/data/1048477/000162828026060572/wk-form4_1788475269.xml",
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"note": "Filed 2026-09-03.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526386794": {
"title": "SEC Form 4, BLTE, Lin Yu-Hsin",
"url": "https://www.sec.gov/Archives/edgar/data/1889109/000119312526386794/ownership.xml",
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"note": "Filed 2026-09-09.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526386790": {
"title": "SEC Form 4, BLTE, Chuang Hao-Yuan",
"url": "https://www.sec.gov/Archives/edgar/data/1889109/000119312526386790/ownership.xml",
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"note": "Filed 2026-09-09.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"form4_000119312526350218": {
"title": "SEC Form 4, BLTE, Chuang Hao-Yuan",
"url": "https://www.sec.gov/Archives/edgar/data/1889109/000119312526350218/ownership.xml",
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"note": "Filed 2026-08-14.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, BLTE, Lin Yu-Hsin",
"url": "https://www.sec.gov/Archives/edgar/data/1889109/000119312526350217/ownership.xml",
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"note": "Filed 2026-08-14.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, CGEM, Michaelson Jennifer",
"url": "https://www.sec.gov/Archives/edgar/data/1789972/000119312526387381/ownership.xml",
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"note": "Filed 2026-09-10.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, CGEM, Michaelson Jennifer",
"url": "https://www.sec.gov/Archives/edgar/data/1789972/000119312526352523/ownership.xml",
"kind": "public",
"note": "Filed 2026-08-14.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, CGEM, Michaelson Jennifer",
"url": "https://www.sec.gov/Archives/edgar/data/1789972/000119312526297605/ownership.xml",
"kind": "public",
"note": "Filed 2026-07-07.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"url": "https://www.sec.gov/Archives/edgar/data/1652130/000119312526363567/ownership.xml",
"kind": "public",
"note": "Filed 2026-08-24.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"title": "SEC Form 4, NTLA, Dulac Edward J III",
"url": "https://www.sec.gov/Archives/edgar/data/1652130/000119312526316279/ownership.xml",
"kind": "public",
"note": "Filed 2026-07-24.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
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"url": "https://query1.finance.yahoo.com/v8/finance/chart/TLX?period1=1741910400&period2=1746662400&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_capr_2025-07-11": {
"title": "Yahoo Finance daily closes, CAPR around 2025-07-11",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/CAPR?period1=1748304000&period2=1753056000&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_rare_2025-07-11": {
"title": "Yahoo Finance daily closes, RARE around 2025-07-11",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/RARE?period1=1748304000&period2=1753056000&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_srrk_2025-09-23": {
"title": "Yahoo Finance daily closes, SRRK around 2025-09-23",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/SRRK?period1=1754697600&period2=1759449600&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_lly_2026-04-01": {
"title": "Yahoo Finance daily closes, LLY around 2026-04-01",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/LLY?period1=1771113600&period2=1775865600&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_azn_2026-05-15": {
"title": "Yahoo Finance daily closes, AZN around 2026-05-15",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/AZN?period1=1774915200&period2=1779667200&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_tak_2026-08-05": {
"title": "Yahoo Finance daily closes, TAK around 2026-08-05",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/TAK?period1=1782000000&period2=1786752000&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_ptgx_2026-08-28": {
"title": "Yahoo Finance daily closes, PTGX around 2026-08-28",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/PTGX?period1=1783987200&period2=1788739200&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_tlx_2026-09-11": {
"title": "Yahoo Finance daily closes, TLX around 2026-09-11",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/TLX?period1=1785196800&period2=1789948800&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_srrk_2026-09-11": {
"title": "Yahoo Finance daily closes, SRRK around 2026-09-11",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/SRRK?period1=1785196800&period2=1789948800&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"yahoo_rare_2026-09-17": {
"title": "Yahoo Finance daily closes, RARE around 2026-09-17",
"url": "https://query1.finance.yahoo.com/v8/finance/chart/RARE?period1=1785715200&period2=1790467200&interval=1d",
"kind": "public",
"note": "Closes either side of the announcement.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"announced_ev_capr_crl": {
"title": "The sponsor's own announcement, Deramiocel",
"url": "https://www.sec.gov/Archives/edgar/data/1133869/000155837025009186/capr-20250711x8k.htm",
"kind": "public",
"note": "Quoted in the FDA's Own Words view beside the FDA's letter.",
"checked": "2026-10-05",
"cited_by": "the FDA's Own Words view"
},
"announced_ev_srrk_crl": {
"title": "The sponsor's own announcement, Apitegromab (Isembyld)",
"url": "https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_8k.htm",
"kind": "public",
"note": "Quoted in the FDA's Own Words view beside the FDA's letter.",
"checked": "2026-10-05",
"cited_by": "the FDA's Own Words view"
},
"announced_ev_tlx_crl": {
"title": "The sponsor's own announcement, Pixclara (floretyrosine F 18)",
"url": "https://www.sec.gov/Archives/edgar/data/2007191/000200719125000049/pix6k.htm",
"kind": "public",
"note": "Quoted in the FDA's Own Words view beside the FDA's letter.",
"checked": "2026-10-05",
"cited_by": "the FDA's Own Words view"
},
"sec_pdufa_0000310158_2026-10-10": {
"title": "SEC filing, Merck & Co., Inc., decision date 2026-10-10",
"url": "https://www.sec.gov/Archives/edgar/data/310158/000031015826000212/mrk-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-07, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001228627_2026-10-17": {
"title": "SEC filing, Opus Genetics, Inc., decision date 2026-10-17",
"url": "https://www.sec.gov/Archives/edgar/data/1228627/000114036126008621/ef20067388_ex99-1.htm",
"kind": "public",
"note": "Filed 2026-03-10, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001802665_2026-10-22": {
"title": "SEC filing, Harmony Biosciences Holdings, Inc., decision date 2026-10-22",
"url": "https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d1.htm",
"kind": "public",
"note": "Filed 2026-08-04, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001828316_2026-10-24": {
"title": "SEC filing, Pharming Group N.V., decision date 2026-10-24",
"url": "https://www.sec.gov/Archives/edgar/data/1828316/000182831626000033/a2026hy1pressrelease.htm",
"kind": "public",
"note": "Filed 2026-07-30, form 6-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0000874015_2026-10-26": {
"title": "SEC filing, IONIS PHARMACEUTICALS INC, decision date 2026-10-26",
"url": "https://www.sec.gov/Archives/edgar/data/874015/000114036126029960/ef20078953_ex99-1.htm",
"kind": "public",
"note": "Filed 2026-07-29, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001055726_2026-10-30": {
"title": "SEC filing, INOVIO PHARMACEUTICALS, INC., decision date 2026-10-30",
"url": "https://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htm",
"kind": "public",
"note": "Filed 2026-08-12, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001439222_2026-11-01": {
"title": "SEC filing, AGIOS PHARMACEUTICALS, INC., decision date 2026-11-01",
"url": "https://www.sec.gov/Archives/edgar/data/1439222/000143922226000115/agio-73026xfyxex991earning.htm",
"kind": "public",
"note": "Filed 2026-07-30, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001599298_2026-11-14": {
"title": "SEC filing, Summit Therapeutics Inc., decision date 2026-11-14",
"url": "https://www.sec.gov/Archives/edgar/data/1599298/000119312526405776/d178892dex991.htm",
"kind": "public",
"note": "Filed 2026-09-29, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001720893_2026-11-14": {
"title": "SEC filing, BioXcel Therapeutics, Inc., decision date 2026-11-14",
"url": "https://www.sec.gov/Archives/edgar/data/1720893/000110465926095965/btai-20260630x10q.htm",
"kind": "public",
"note": "Filed 2026-08-13, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001061983_2026-11-14": {
"title": "SEC filing, CYTOKINETICS INC, decision date 2026-11-14",
"url": "https://www.sec.gov/Archives/edgar/data/1061983/000119312526338217/cytk-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001133869_2026-11-22": {
"title": "SEC filing, CAPRICOR THERAPEUTICS, INC., decision date 2026-11-22",
"url": "https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htm",
"kind": "public",
"note": "Filed 2026-08-24, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001160308_2026-11-22": {
"title": "SEC filing, Savara Inc, decision date 2026-11-22",
"url": "https://www.sec.gov/Archives/edgar/data/1160308/000119312526344585/svra-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-11, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001121404_2026-11-25": {
"title": "SEC filing, Sanofi, decision date 2026-11-25",
"url": "https://www.sec.gov/Archives/edgar/data/1121404/000112140426000008/pressreleaseq22026english.htm",
"kind": "public",
"note": "Filed 2026-07-30, form 6-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001743881_2026-11-27": {
"title": "SEC filing, BridgeBio Pharma, Inc., decision date 2026-11-27",
"url": "https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htm",
"kind": "public",
"note": "Filed 2026-08-31, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001802768_2026-11-27": {
"title": "SEC filing, Royalty Pharma plc, decision date 2026-11-27",
"url": "https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htm",
"kind": "public",
"note": "Filed 2026-08-05, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001611842_2026-11-28": {
"title": "SEC filing, PolyPid Ltd., decision date 2026-11-28",
"url": "https://www.sec.gov/Archives/edgar/data/1611842/000121390026105492/ea030731601ex99-1.htm",
"kind": "public",
"note": "Filed 2026-10-01, form 6-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001798749_2026-11-30": {
"title": "SEC filing, Jade Biosciences, Inc., decision date 2026-11-30",
"url": "https://www.sec.gov/Archives/edgar/data/1798749/000119312526341242/ck0001798749-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-10, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001704292_2026-11-30": {
"title": "SEC filing, Zai Lab Ltd, decision date 2026-11-30",
"url": "https://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0000875320_2026-11-30": {
"title": "SEC filing, VERTEX PHARMACEUTICALS INC / MA, decision date 2026-11-30",
"url": "https://www.sec.gov/Archives/edgar/data/875320/000087532026000259/vrtx-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-04, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0000939767_2026-12-03": {
"title": "SEC filing, EXELIXIS, INC., decision date 2026-12-03",
"url": "https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm",
"kind": "public",
"note": "Filed 2026-08-05, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001347178_2026-12-12": {
"title": "SEC filing, Vanda Pharmaceuticals Inc., decision date 2026-12-12",
"url": "https://www.sec.gov/Archives/edgar/data/1347178/000162828026053855/vnda-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001370053_2026-12-12": {
"title": "SEC filing, ANAPTYSBIO, INC, decision date 2026-12-12",
"url": "https://www.sec.gov/Archives/edgar/data/1370053/000119312526219515/anab-20260331.htm",
"kind": "public",
"note": "Filed 2026-05-12, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001088856_2026-12-17": {
"title": "SEC filing, CORCEPT THERAPEUTICS INC, decision date 2026-12-17",
"url": "https://www.sec.gov/Archives/edgar/data/1088856/000162828026050607/cort072926ex991pressrelease.htm",
"kind": "public",
"note": "Filed 2026-07-29, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001933414_2026-12-22": {
"title": "SEC filing, Mineralys Therapeutics, Inc., decision date 2026-12-22",
"url": "https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/mlys202603068kex991.htm",
"kind": "public",
"note": "Filed 2026-03-09, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0000882095_2026-12-23": {
"title": "SEC filing, GILEAD SCIENCES, INC., decision date 2026-12-23",
"url": "https://www.sec.gov/Archives/edgar/data/882095/000088209526000031/gild-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001689548_2026-12-27": {
"title": "SEC filing, Praxis Precision Medicines, Inc., decision date 2026-12-27",
"url": "https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001792044_2026-12-27": {
"title": "SEC filing, Viatris Inc, decision date 2026-12-27",
"url": "https://www.sec.gov/Archives/edgar/data/1792044/000179204426000037/exhibit991-2q26earningsrel.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001811063_2027-01-04": {
"title": "SEC filing, Nuvation Bio Inc., decision date 2027-01-04",
"url": "https://www.sec.gov/Archives/edgar/data/1811063/000119312526336751/d261840dex991.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001326110_2027-01-06": {
"title": "SEC filing, ImmunityBio, Inc., decision date 2027-01-06",
"url": "https://www.sec.gov/Archives/edgar/data/1326110/000132611026000077/ibrx-202684x8kexhibit991.htm",
"kind": "public",
"note": "Filed 2026-08-04, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001818794_2027-01-21": {
"title": "SEC filing, Dyne Therapeutics, Inc., decision date 2027-01-21",
"url": "https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htm",
"kind": "public",
"note": "Filed 2026-07-29, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001828316_2027-01-30": {
"title": "SEC filing, Pharming Group N.V., decision date 2027-01-30",
"url": "https://www.sec.gov/Archives/edgar/data/1828316/000182831626000041/pharmingannouncesusfdaacce.htm",
"kind": "public",
"note": "Filed 2026-09-25, form 6-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001889109_2027-02-12": {
"title": "SEC filing, BELITE BIO, INC, decision date 2027-02-12",
"url": "https://www.sec.gov/Archives/edgar/data/1889109/000110465926105608/tm2624806d1_ex99-1.htm",
"kind": "public",
"note": "Filed 2026-09-08, form 6-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001787306_2027-02-23": {
"title": "SEC filing, Arcutis Biotherapeutics, Inc., decision date 2027-02-23",
"url": "https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htm",
"kind": "public",
"note": "Filed 2026-08-05, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001868279_2027-02-27": {
"title": "SEC filing, ArriVent BioPharma, Inc., decision date 2027-02-27",
"url": "https://www.sec.gov/Archives/edgar/data/1868279/000110465926094902/avbp-20260630x10q.htm",
"kind": "public",
"note": "Filed 2026-08-12, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001745648_2027-02-28": {
"title": "SEC filing, Apnimed, Inc., decision date 2027-02-28",
"url": "https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htm",
"kind": "public",
"note": "Filed 2026-09-08, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001048477_2027-02-28": {
"title": "SEC filing, BIOMARIN PHARMACEUTICAL INC, decision date 2027-02-28",
"url": "https://www.sec.gov/Archives/edgar/data/1048477/000104847726000015/earningsrelease-6aug26ex991.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001652130_2027-03-10": {
"title": "SEC filing, Intellia Therapeutics, Inc., decision date 2027-03-10",
"url": "https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htm",
"kind": "public",
"note": "Filed 2026-09-08, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0000014272_2027-03-11": {
"title": "SEC filing, BRISTOL MYERS SQUIBB CO, decision date 2027-03-11",
"url": "https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htm",
"kind": "public",
"note": "Filed 2026-07-30, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0002007919_2027-04-14": {
"title": "SEC filing, Inhibrx Biosciences, Inc., decision date 2027-04-14",
"url": "https://www.sec.gov/Archives/edgar/data/2007919/000200791926000044/exhibit99106302026.htm",
"kind": "public",
"note": "Filed 2026-08-13, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001830487_2027-04-23": {
"title": "SEC filing, Pharvaris N.V., decision date 2027-04-23",
"url": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526345702/phvs-ex99_2.htm",
"kind": "public",
"note": "Filed 2026-08-12, form 6-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001661181_2027-04-24": {
"title": "SEC filing, Organogenesis Holdings Inc., decision date 2027-04-24",
"url": "https://www.sec.gov/Archives/edgar/data/1661181/000119312526338049/orgo-20260630.htm",
"kind": "public",
"note": "Filed 2026-08-06, form 10-Q.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001472012_2027-04-28": {
"title": "SEC filing, Immunome Inc., decision date 2027-04-28",
"url": "https://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htm",
"kind": "public",
"note": "Filed 2026-08-11, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001579428_2027-05-01": {
"title": "SEC filing, Axsome Therapeutics, Inc., decision date 2027-05-01",
"url": "https://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htm",
"kind": "public",
"note": "Filed 2026-08-10, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001743881_2027-05-08": {
"title": "SEC filing, BridgeBio Pharma, Inc., decision date 2027-05-08",
"url": "https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm",
"kind": "public",
"note": "Filed 2026-08-10, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
},
"sec_pdufa_0001953926_2027-05-27": {
"title": "SEC filing, Zenas BioPharma, Inc., decision date 2027-05-27",
"url": "https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htm",
"kind": "public",
"note": "Filed 2026-08-13, form 8-K.",
"checked": "2026-10-05",
"cited_by": "the What the Market Prices view"
}
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{
"id": "idxd",
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{
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{
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{
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{
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{
"id": "lorundrostat",
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},
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{
"id": "anito_cel",
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},
{
"id": "bezuclastinib_nonadvsm",
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},
{
"id": "cagrisema",
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},
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},
{
"id": "tinlarebant",
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},
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},
{
"id": "zipalertinib",
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},
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"adverse_detail": [
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]
},
{
"id": "vosoritide",
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},
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},
{
"id": "lonvo_z",
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},
"price": 12.26,
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"adverse_detail": [
"FDA request for preclinical fetal data"
]
},
{
"id": "deucrictibant",
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},
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},
{
"id": "bezuclastinib_advsm",
"drug": "Bezuclastinib (AdvSM)",
"company": "Cogent Bio",
"ticker": "COGT",
"pdufa": "2027-06-29",
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"status": "pending",
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},
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"target": 55.82,
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},
{
"id": "apitegromab",
"drug": "Apitegromab (Isembyld)",
"company": "Scholar Rock",
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"review": "priority",
"status": "approved",
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},
"price": 46.81,
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"market_src": "https://stockanalysis.com/stocks/SRRK/",
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"adverse": 1,
"adverse_detail": [
"Complete response letter"
]
},
{
"id": "baxdrostat",
"drug": "Baxdrostat (Baxfendy)",
"company": "AstraZeneca",
"ticker": "AZN",
"pdufa": null,
"review": "priority",
"status": "approved",
"modality": "small molecule",
"ranked": true,
"components": {
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},
"price": 156.9,
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"market_src": "https://stockanalysis.com/stocks/AZN/",
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"adverse": 0,
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},
{
"id": "deucrictibant_xr",
"drug": "Deucrictibant XR",
"company": "Pharvaris",
"ticker": "PHVS",
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"review": "none",
"status": "not_filed",
"modality": "oral small molecule",
"ranked": false,
"components": {
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"adverse": 0
},
"price": 31.19,
"target": 57.58,
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"market_state": "quoted",
"market_src": "https://stockanalysis.com/stocks/PHVS/",
"not_ranked_because": "Not filed. It carries no PDUFA date, so there is no decision to stand it beside.",
"trials": 1,
"precedent": 1,
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"adverse": 0,
"adverse_detail": []
},
{
"id": "icatibant",
"drug": "Icatibant (Firazyr)",
"company": "Jerini, acquired by Shire",
"ticker": "private",
"pdufa": null,
"review": "none",
"status": "approved",
"modality": "peptide",
"ranked": true,
"components": {
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},
"price": 0,
"target": 0,
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"currency": "USD",
"market_state": "not listed",
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"adverse_detail": []
},
{
"id": "orforglipron",
"drug": "Orforglipron (Foundayo)",
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"ticker": "LLY",
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"review": "standard",
"status": "approved",
"modality": "oral small molecule",
"ranked": true,
"components": {
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},
"price": 1142.85,
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"upside_pct": 16.27,
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"market_state": "quoted",
"market_src": "https://stockanalysis.com/stocks/LLY/",
"not_ranked_because": null,
"trials": 18,
"precedent": 0,
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"adverse": 0,
"adverse_detail": []
},
{
"id": "oveporexton",
"drug": "Oveporexton (Orzeyful)",
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"ticker": "TAK",
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"review": "priority",
"status": "approved",
"modality": "small molecule",
"ranked": true,
"components": {
"trials": 3,
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},
"price": 17.86,
"target": 22.07,
"upside_pct": 23.57,
"mcap_usd": 57130000000,
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"currency": "USD",
"market_state": "quoted",
"market_src": "https://stockanalysis.com/stocks/TAK/",
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"adverse_detail": []
},
{
"id": "pixclara",
"drug": "Pixclara (floretyrosine F 18)",
"company": "Telix Pharmaceuticals",
"ticker": "TLX",
"pdufa": null,
"review": "priority",
"status": "approved",
"modality": "PET imaging agent",
"ranked": true,
"components": {
"trials": 0,
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},
"price": 10.55,
"target": 19.6,
"upside_pct": 85.78,
"mcap_usd": 3580000000,
"mcap_jpy": null,
"currency": "USD",
"market_state": "quoted",
"market_src": "https://stockanalysis.com/stocks/TLX/",
"not_ranked_because": null,
"trials": 0,
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"closed_loop": 0,
"adverse": 1,
"adverse_detail": [
"Complete response letter"
]
},
{
"id": "rusfertide",
"drug": "Rusfertide (Mimrylo)",
"company": "Takeda and Protagonist Therapeutics",
"ticker": "PTGX",
"pdufa": null,
"review": "priority",
"status": "approved",
"modality": "peptide",
"ranked": true,
"components": {
"trials": 0,
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"adverse": 0
},
"price": 140.06,
"target": 174.69,
"upside_pct": 24.73,
"mcap_usd": 9060000000,
"mcap_jpy": null,
"currency": "USD",
"market_state": "quoted",
"market_src": "https://stockanalysis.com/stocks/PTGX/",
"not_ranked_because": null,
"trials": 0,
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"adverse": 0,
"adverse_detail": []
},
{
"id": "zipalertinib_1l",
"drug": "Zipalertinib + chemotherapy (first line)",
"company": "Cullinan",
"ticker": "CGEM",
"pdufa": null,
"review": "none",
"status": "not_filed",
"modality": "small molecule",
"ranked": false,
"components": {
"trials": 0,
"precedent": 0,
"closed_loop": 0,
"adverse": 0
},
"price": 15.51,
"target": 33.45,
"upside_pct": 115.67,
"mcap_usd": 998140000,
"mcap_jpy": null,
"currency": "USD",
"market_state": "quoted",
"market_src": "https://stockanalysis.com/stocks/CGEM/",
"not_ranked_because": "Not filed. It carries no PDUFA date, so there is no decision to stand it beside.",
"trials": 0,
"precedent": 0,
"closed_loop": 0,
"adverse": 0,
"adverse_detail": []
}
],
"score": {
"weights": {
"trials": 1,
"precedent": 2,
"closed_loop": 2,
"adverse": -2
},
"adverse_kinds": [
"adcom_against",
"crl",
"extension",
"info_request",
"rtf",
"safety_signal"
],
"withdrawn": {
"on": "2026-09-23",
"formula_was": "trials + 2*precedent + 2*closed_loop - 2*adverse",
"what_the_room_published": "That the formula failed its own backtest, and that the cause was adverse events being charged and never credited back.",
"what_was_actually_true": "The cause was the record, not the formula. One of eight approved drugs carried a registrational trial and nine of twelve pending ones did, because the record was built as a screen of live filings and the approved names were entered as outcomes. Of the 1.45 point gap between the cohorts, 0.71 came from trials, 0.33 from precedent, 0.33 from closed loops and 0.08 from the adverse term the published finding blamed.",
"what_fixing_it_showed": "Both cohorts were then searched by one rule. The gap closed and the sign flipped, approved +3.38 against pending +3.08. The ranking that produced was topped by CagriSema on 22 registered phase 3 studies and Orforglipron on 18. The trials term counts studies, so it measures which sponsor can afford to run them. The formula could be made to pass its test, and a ranking topped by the three largest sponsors on the board is a proxy for market capitalisation.",
"what_replaces_it": "Nothing, and that is deliberate. The board is ordered by regulatory standing, which is read from dated events each carrying its own source, and then by implied upside. The components of the old score are kept and shown per drug, because each is a counted fact.",
"cohort_means": {
"trials": {
"approved": 4.25,
"pending": 2.69
},
"precedent": {
"approved": 0.0,
"pending": 0.15
},
"closed_loop": {
"approved": 0.0,
"pending": 0.15
},
"adverse": {
"approved": 0.38,
"pending": 0.31
}
}
},
"ranked_n": 22
},
"scope": {
"search": [
{
"query": "previously_shipped",
"people_in_graph": 6,
"people_searched": 6,
"people_returning_a_result": 2,
"note": "All 6 named executives were searched for a prior approved drug. Only Modig and Knolle return one, both to icatibant. Leonard, Congleton, Pauls and Ahmed carry no prior approval that this search found. That is a searched-and-found-nothing result on 6 people, not a survey of every executive in the sector, and the room states it that way."
}
],
"exclusions": [
{
"drug": "deramiocel",
"rule": "Carried in the record but 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. The score is built to compare filings that are still on their original footing. Excluding it is a judgment, so the drug, its live 22 November 2026 PDUFA and the vote against it all stay visible."
}
]
},
"letters": [
{
"drug": "Pixclara (floretyrosine F 18)",
"drug_id": "pixclara",
"company": "Telix Pharmaceuticals",
"ticker": "TLX",
"application": "NDA 218592",
"letter_date": "2025-04-25",
"announced_on": "2025-04-28",
"gap_days": 3,
"sections": [
"chemistry, manufacturing and controls",
"clinical / statistical"
],
"fda_quote": "The clinical data submitted in this application did not provide substantial evidence of effectiveness for floretyrosine F 18.",
"fda_url": "https://download.open.fda.gov/crl/CRL_NDA218592_20250425.pdf",
"second_finding": null,
"also_reported": {
"url": "https://www.sec.gov/Archives/edgar/data/2007191/000200719125000049/pix6k.htm",
"quote": "On 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.",
"recorded_at": "2026-10-05",
"note": "Exhibit 99.1 of the same filing (pixpr.htm) is the release stating the complete response letter. 28 April in Melbourne is the evening of 27 April in New York, before the US open on the 28th."
},
"corrected_value": null,
"outcome": "approved",
"outcome_on": "2026-09-11",
"months_to_outcome": 17
},
{
"drug": "Fayuvi (rebisufligene etisparvovec-hopf)",
"drug_id": "fayuvi",
"company": "Ultragenyx",
"ticker": "RARE",
"application": "BL 125845",
"letter_date": "2025-07-07",
"announced_on": "2025-07-11",
"gap_days": 4,
"sections": [
"chemistry, manufacturing and controls",
"facility inspection"
],
"fda_quote": "Pursuant 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.",
"fda_url": "https://download.open.fda.gov/crl/CRL_BLA125845_20250707.pdf",
"second_finding": {
"quote": "We are currently evaluating the clinical data to determine if it adequately supports the proposed indication.",
"url": "https://download.open.fda.gov/crl/CRL_BLA125845_20250707.pdf",
"recorded_at": "2026-09-23"
},
"also_reported": {
"url": "https://www.drugs.com/history/fayuvi.html",
"quote": "Jul 11, 2025 Ultragenyx Receives Complete Response Letter from FDA for UX111",
"recorded_at": "2026-09-22",
"note": "the account published by or about the sponsor, kept as reported"
},
"corrected_value": null,
"outcome": "approved",
"outcome_on": "2026-09-17",
"months_to_outcome": 14
},
{
"drug": "Deramiocel",
"drug_id": "deramiocel",
"company": "Capricor",
"ticker": "CAPR",
"application": "BL 125842",
"letter_date": "2025-07-09",
"announced_on": "2025-07-11",
"gap_days": 2,
"sections": [
"chemistry, manufacturing and controls",
"clinical / statistical"
],
"fda_quote": "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.",
"fda_url": "https://download.open.fda.gov/crl/CRL_BLA125842_20250709.pdf",
"second_finding": null,
"also_reported": {
"url": "https://www.sec.gov/Archives/edgar/data/1133869/000155837025009186/capr-20250711x8k.htm",
"quote": "On 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).",
"recorded_at": "2026-10-05"
},
"corrected_value": {
"field": "date",
"was": "2025-07-01",
"now": "2025-07-09",
"corrected_on": "2026-09-23",
"why": "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."
},
"outcome": "excluded",
"outcome_on": null,
"months_to_outcome": null
},
{
"drug": "Apitegromab (Isembyld)",
"drug_id": "apitegromab",
"company": "Scholar Rock",
"ticker": "SRRK",
"application": "BLA 761463",
"letter_date": "2025-09-22",
"announced_on": "2025-09-23",
"gap_days": 1,
"sections": [
"chemistry, manufacturing and controls",
"facility inspection"
],
"fda_quote": "The deficiencies identified during the inspection may not be specific to your application.",
"fda_url": "https://download.open.fda.gov/crl/CRL_BLA761463_20250922.pdf",
"second_finding": null,
"also_reported": {
"url": "https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_8k.htm",
"quote": "On September 23, 2025, the Company announced that the FDA has issued a CRL regarding the BLA for apitegromab for the treatment of SMA.",
"recorded_at": "2026-10-05"
},
"corrected_value": null,
"outcome": "approved",
"outcome_on": "2026-09-11",
"months_to_outcome": 12
}
],
"crl_corpus": {
"total": 458,
"approved_after": 309,
"still_unapproved": 149,
"last_updated": "2026-08-13",
"url": "https://open.fda.gov/apis/transparency/completeresponseletters/",
"api": "https://api.fda.gov/transparency/crl.json",
"checked": "2026-09-23",
"what_the_split_is_not": "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.",
"documentation_understates_it": "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."
},
"trials": [
{
"trial": "iMMagine-3",
"id": "t_nct06413498",
"drug": "Anito-cel",
"drug_id": "anito_cel",
"company": "Arcellx, acquired by Gilead",
"ticker": "ACLX",
"status_on_board": "pending",
"result": "",
"n": 452,
"nct": "NCT06413498",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 452,
"primary_completion": "2028-07",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06413498",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "Bax24",
"id": "t_nct06168409",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 218,
"nct": "NCT06168409",
"registry_status": "COMPLETED",
"registry_enrolment": 218,
"primary_completion": "2025-08-17",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06168409",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "BaxAsia",
"id": "t_nct06344104",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 326,
"nct": "NCT06344104",
"registry_status": "COMPLETED",
"registry_enrolment": 326,
"primary_completion": "2025-11-24",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06344104",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "BaxDuo-Pacific",
"id": "t_nct06742723",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 5000,
"nct": "NCT06742723",
"registry_status": "RECRUITING",
"registry_enrolment": 5000,
"primary_completion": "2029-12-18",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06742723",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "BaxHTN",
"id": "t_nct06034743",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 796,
"nct": "NCT06034743",
"registry_status": "COMPLETED",
"registry_enrolment": 796,
"primary_completion": "2025-05-21",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06034743",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "BaxNoD",
"id": "t_nct07686120",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 286,
"nct": "NCT07686120",
"registry_status": "NOT_YET_RECRUITING",
"registry_enrolment": 286,
"primary_completion": "2028-02-09",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07686120",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "BaxPA",
"id": "t_nct07007793",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 250,
"nct": "NCT07007793",
"registry_status": "RECRUITING",
"registry_enrolment": 250,
"primary_completion": "2027-08-13",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07007793",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "BaxREMODEL",
"id": "t_nct07655362",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 286,
"nct": "NCT07655362",
"registry_status": "NOT_YET_RECRUITING",
"registry_enrolment": 286,
"primary_completion": "2028-06-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07655362",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "NCT06268873",
"id": "t_nct06268873",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 2554,
"nct": "NCT06268873",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 2554,
"primary_completion": "2028-02-24",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06268873",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "Prevent-HF",
"id": "t_nct06677060",
"drug": "Baxdrostat (Baxfendy)",
"drug_id": "baxdrostat",
"company": "AstraZeneca",
"ticker": "AZN",
"status_on_board": "approved",
"result": "",
"n": 11300,
"nct": "NCT06677060",
"registry_status": "RECRUITING",
"registry_enrolment": 11300,
"primary_completion": "2029-12-17",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06677060",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "DRAGON",
"id": "dragon",
"drug": "Tinlarebant",
"drug_id": "tinlarebant",
"company": "Belite Bio",
"ticker": "BLTE",
"status_on_board": "pending",
"result": "35.7% reduction in lesion growth",
"n": 104,
"nct": "NCT05244304",
"registry_status": "COMPLETED",
"registry_enrolment": 104,
"primary_completion": "2025-08-04",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05244304",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "PHOENIX",
"id": "t_nct05949593",
"drug": "Tinlarebant",
"drug_id": "tinlarebant",
"company": "Belite Bio",
"ticker": "BLTE",
"status_on_board": "pending",
"result": "",
"n": 429,
"nct": "NCT05949593",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 429,
"primary_completion": "2027-06-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05949593",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "CANOPY-HCH-3",
"id": "t_nct06455059",
"drug": "Vosoritide (Voxzogo)",
"drug_id": "vosoritide",
"company": "BioMarin",
"ticker": "BMRN",
"status_on_board": "pending",
"result": "",
"n": 80,
"nct": "NCT06455059",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 80,
"primary_completion": "2026-08-01",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06455059",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "NCT03197766",
"id": "t_nct03197766",
"drug": "Vosoritide (Voxzogo)",
"drug_id": "vosoritide",
"company": "BioMarin",
"ticker": "BMRN",
"status_on_board": "pending",
"result": "",
"n": 121,
"nct": "NCT03197766",
"registry_status": "COMPLETED",
"registry_enrolment": 121,
"primary_completion": "2019-10-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT03197766",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "FORTIFY",
"id": "fortify",
"drug": "BBP-418",
"drug_id": "bbp_418",
"company": "BridgeBio",
"ticker": "BBIO",
"status_on_board": "pending",
"result": "interim consistent efficacy",
"n": 112,
"nct": "NCT05775848",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 112,
"primary_completion": "2027-09",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05775848",
"agreed_on": [
"name",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "HOPE-3",
"id": "hope3",
"drug": "Deramiocel",
"drug_id": "deramiocel",
"company": "Capricor",
"ticker": "CAPR",
"status_on_board": "excluded",
"result": "54% slowing PUL decline p=0.029",
"n": 106,
"nct": "NCT05126758",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 106,
"primary_completion": "2025-06-18",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05126758",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "APEX",
"id": "apex",
"drug": "Bezuclastinib",
"drug_id": "bezuclastinib",
"company": "Cogent Bio",
"ticker": "COGT",
"status_on_board": "pending",
"result": "ORR 65%, CR 57%",
"n": 140,
"nct": "NCT04996875",
"registry_status": "RECRUITING",
"registry_enrolment": 140,
"primary_completion": "2025-09-19",
"phase": "PHASE2",
"url": "https://clinicaltrials.gov/study/NCT04996875",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "PEAK",
"id": "t_nct05208047",
"drug": "Bezuclastinib",
"drug_id": "bezuclastinib",
"company": "Cogent Bio",
"ticker": "COGT",
"status_on_board": "pending",
"result": "PFS HR 0.50, mPFS 16.5 v 9.2 months",
"n": 482,
"nct": "NCT05208047",
"registry_status": "RECRUITING",
"registry_enrolment": 482,
"primary_completion": "2025-09-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05208047",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REZILIENT1",
"id": "rezilient1",
"drug": "Zipalertinib",
"drug_id": "zipalertinib",
"company": "Cullinan",
"ticker": "CGEM",
"status_on_board": "pending",
"result": "ORR 35%, mDOR 8.8 months",
"n": 176,
"nct": "NCT04036682",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 284,
"primary_completion": "2025-10-13",
"phase": "PHASE1,PHASE2",
"url": "https://clinicaltrials.gov/study/NCT04036682",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": {
"ours": 176,
"registry": 284,
"url": "https://clinicaltrials.gov/study/NCT04036682",
"checked": "2026-09-23"
},
"n_from_registry": false
},
{
"trial": "REZILIENT3",
"id": "rezilient3",
"drug": "Zipalertinib",
"drug_id": "zipalertinib",
"company": "Cullinan",
"ticker": "CGEM",
"status_on_board": "pending",
"result": "50% reduction in risk of progression, 1L",
"n": 285,
"nct": "NCT05973773",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 285,
"primary_completion": "2027-05-27",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05973773",
"agreed_on": [
"name",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "IDeate-Lung01",
"id": "ideate1",
"drug": "Ifinatamab deruxtecan",
"drug_id": "idxd",
"company": "Daiichi Sankyo",
"ticker": "TSE:4568",
"status_on_board": "withdrawn",
"result": "ORR 48.2%",
"n": 187,
"nct": "NCT05280470",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 187,
"primary_completion": "2025-03-03",
"phase": "PHASE2",
"url": "https://clinicaltrials.gov/study/NCT05280470",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "IDeate-Lung02",
"id": "t_nct06203210",
"drug": "Ifinatamab deruxtecan",
"drug_id": "idxd",
"company": "Daiichi Sankyo",
"ticker": "TSE:4568",
"status_on_board": "withdrawn",
"result": "",
"n": 540,
"nct": "NCT06203210",
"registry_status": "RECRUITING",
"registry_enrolment": 540,
"primary_completion": "2028-01-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06203210",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
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{
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"n": 2500,
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"registry_status": "RECRUITING",
"registry_enrolment": 2500,
"primary_completion": "2028-02-23",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07564414",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "NCT07817251",
"id": "t_nct07817251",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 210,
"nct": "NCT07817251",
"registry_status": "NOT_YET_RECRUITING",
"registry_enrolment": 210,
"primary_completion": "2027-06-09",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07817251",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REDEFINE 1",
"id": "t_nct05567796",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 3400,
"nct": "NCT05567796",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 3400,
"primary_completion": "2024-10-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05567796",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REDEFINE 2",
"id": "t_nct05394519",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 1200,
"nct": "NCT05394519",
"registry_status": "COMPLETED",
"registry_enrolment": 1200,
"primary_completion": "2025-01-28",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05394519",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REDEFINE 3",
"id": "t_nct05669755",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 7101,
"nct": "NCT05669755",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 7101,
"primary_completion": "2027-09-01",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05669755",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REDEFINE 6",
"id": "t_nct05996848",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 300,
"nct": "NCT05996848",
"registry_status": "COMPLETED",
"registry_enrolment": 300,
"primary_completion": "2025-01-06",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05996848",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REIMAGINE 1",
"id": "t_nct06323174",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 189,
"nct": "NCT06323174",
"registry_status": "COMPLETED",
"registry_enrolment": 189,
"primary_completion": "2025-10-01",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06323174",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REIMAGINE 2",
"id": "t_nct06065540",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 2734,
"nct": "NCT06065540",
"registry_status": "COMPLETED",
"registry_enrolment": 2734,
"primary_completion": "2025-11-19",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06065540",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REIMAGINE 3",
"id": "t_nct06323161",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 274,
"nct": "NCT06323161",
"registry_status": "COMPLETED",
"registry_enrolment": 274,
"primary_completion": "2025-09-09",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06323161",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REIMAGINE 5",
"id": "t_nct06534411",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 1023,
"nct": "NCT06534411",
"registry_status": "COMPLETED",
"registry_enrolment": 1023,
"primary_completion": "2026-06-02",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06534411",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "REIMAGINEYOUNG",
"id": "t_nct07282613",
"drug": "CagriSema",
"drug_id": "cagrisema",
"company": "Novo Nordisk",
"ticker": "NVO",
"status_on_board": "pending",
"result": "",
"n": 80,
"nct": "NCT07282613",
"registry_status": "RECRUITING",
"registry_enrolment": 80,
"primary_completion": "2029-09-07",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07282613",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "CHAPTER-3",
"id": "chapter3",
"drug": "Deucrictibant XR",
"drug_id": "deucrictibant_xr",
"company": "Pharvaris",
"ticker": "PHVS",
"status_on_board": "not_filed",
"result": "83pc attack reduction all HAE types, 87pc in type 1 and 2",
"n": 85,
"nct": "NCT06669754",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 81,
"primary_completion": "2026-08",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06669754",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": {
"ours": 85,
"registry": 81,
"url": "https://clinicaltrials.gov/study/NCT06669754",
"checked": "2026-09-23"
},
"n_from_registry": false
},
{
"trial": "CHAPTER-4",
"id": "t_nct06679881",
"drug": "Deucrictibant IR",
"drug_id": "deucrictibant",
"company": "Pharvaris",
"ticker": "PHVS",
"status_on_board": "pending",
"result": "",
"n": 170,
"nct": "NCT06679881",
"registry_status": "ENROLLING_BY_INVITATION",
"registry_enrolment": 170,
"primary_completion": "2028-12",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06679881",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "CREAATE",
"id": "t_nct07266805",
"drug": "Deucrictibant IR",
"drug_id": "deucrictibant",
"company": "Pharvaris",
"ticker": "PHVS",
"status_on_board": "pending",
"result": "",
"n": 48,
"nct": "NCT07266805",
"registry_status": "RECRUITING",
"registry_enrolment": 48,
"primary_completion": "2027-06",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07266805",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "RAPIDe-3",
"id": "rapide3",
"drug": "Deucrictibant IR",
"drug_id": "deucrictibant",
"company": "Pharvaris",
"ticker": "PHVS",
"status_on_board": "pending",
"result": "primary and all 11 secondaries met",
"n": 134,
"nct": "NCT06343779",
"registry_status": "COMPLETED",
"registry_enrolment": 134,
"primary_completion": "2025-10-17",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06343779",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "IMPALA-2",
"id": "impala2",
"drug": "Molgramostim",
"drug_id": "molgramostim",
"company": "Savara",
"ticker": "SVRA",
"status_on_board": "pending",
"result": "primary met, DLCO +6.0pp wk24, p<0.001",
"n": 164,
"nct": "NCT04544293",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 164,
"primary_completion": "2023-11-30",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT04544293",
"agreed_on": [
"name",
"sponsor",
"drug named in title"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "ONYX",
"id": "t_nct05626855",
"drug": "Apitegromab (Isembyld)",
"drug_id": "apitegromab",
"company": "Scholar Rock",
"ticker": "SRRK",
"status_on_board": "approved",
"result": "",
"n": 238,
"nct": "NCT05626855",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 238,
"primary_completion": "2026-11-01",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05626855",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "SAPPHIRE",
"id": "t_nct05156320",
"drug": "Apitegromab (Isembyld)",
"drug_id": "apitegromab",
"company": "Scholar Rock",
"ticker": "SRRK",
"status_on_board": "approved",
"result": "",
"n": 188,
"nct": "NCT05156320",
"registry_status": "COMPLETED",
"registry_enrolment": 188,
"primary_completion": "2024-12-18",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT05156320",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "NCT06470828",
"id": "t_nct06470828",
"drug": "Oveporexton (Orzeyful)",
"drug_id": "oveporexton",
"company": "Takeda",
"ticker": "TAK",
"status_on_board": "approved",
"result": "",
"n": 168,
"nct": "NCT06470828",
"registry_status": "COMPLETED",
"registry_enrolment": 168,
"primary_completion": "2025-06-03",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06470828",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "NCT06505031",
"id": "t_nct06505031",
"drug": "Oveporexton (Orzeyful)",
"drug_id": "oveporexton",
"company": "Takeda",
"ticker": "TAK",
"status_on_board": "approved",
"result": "",
"n": 105,
"nct": "NCT06505031",
"registry_status": "COMPLETED",
"registry_enrolment": 105,
"primary_completion": "2025-06-04",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT06505031",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "NCT07363720",
"id": "t_nct07363720",
"drug": "Oveporexton (Orzeyful)",
"drug_id": "oveporexton",
"company": "Takeda",
"ticker": "TAK",
"status_on_board": "approved",
"result": "",
"n": 98,
"nct": "NCT07363720",
"registry_status": "ACTIVE_NOT_RECRUITING",
"registry_enrolment": 98,
"primary_completion": "2026-10-02",
"phase": "PHASE3",
"url": "https://clinicaltrials.gov/study/NCT07363720",
"agreed_on": [
"name",
"drug named in title",
"sponsor"
],
"state": "resolved",
"why": null,
"n_disagrees": null,
"n_from_registry": true
},
{
"trial": "Transpher A",
"id": "transpher_a",
"drug": "Fayuvi (rebisufligene etisparvovec-hopf)",
"drug_id": "fayuvi",
"company": "Ultragenyx",
"ticker": "RARE",
"status_on_board": "approved",
"result": "23.5 point higher Bayley-III cognitive score over natural history, p<0.0001",
"n": 17,
"nct": null,
"registry_status": null,
"registry_enrolment": null,
"primary_completion": null,
"phase": null,
"url": null,
"agreed_on": [],
"state": "unresolved",
"why": "no study in the registry agreed with this record on two independent fields",
"n_disagrees": null,
"n_from_registry": false
}
],
"trial_registry": {
"api": "https://clinicaltrials.gov/api/v2/studies",
"checked": "2026-09-23",
"resolved": 12,
"attempted": 13,
"rule": "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.",
"unresolved": [
{
"trial": "Transpher A",
"why": "no study in the registry agreed with this record on two independent fields"
}
]
},
"adcom_watch": {
"checked": "2026-10-05",
"api": "https://www.federalregister.gov/api/v1/documents.json",
"window_from": "2025-09-01",
"searched": 13,
"named_in_a_notice": 0,
"names": [
"Anito-cel",
"BBP-418",
"Bezuclastinib",
"Bezuclastinib",
"Bezuclastinib",
"CagriSema",
"Deucrictibant",
"Lonvo-z",
"Lorundrostat",
"Molgramostim",
"Tinlarebant",
"Vosoritide",
"Zipalertinib"
],
"not_checked": [],
"what_this_is": "Every name still awaiting an FDA decision on this board, searched by name against Federal Register notices from 2025-09-01 onward. A name with no notice has no advisory committee meeting noticed in the Federal Register as at 2026-10-05.",
"what_this_is_not": "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.",
"control": {
"ran": "2026-10-05",
"found": 2,
"how": "The identical query was run for deramiocel, whose advisory committee sat on 29 July 2026 and voted 9 to 3 against. It returns the 2 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.",
"notices": [
{
"title": "Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)",
"published": "2026-06-29",
"url": "https://www.federalregister.gov/documents/2026/06/29/2026-13096/cellular-tissue-and-gene-therapies-advisory-committee-notice-of-meeting-establishment-of-a-public"
},
{
"title": "Cellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)",
"published": "2026-07-24",
"url": "https://www.federalregister.gov/documents/2026/07/24/2026-15016/cellular-tissue-and-gene-therapies-advisory-committee-amendment-of-notice-biologics-license"
}
]
}
},
"pivotal_sweep": {
"checked": "2026-09-23",
"api": "https://clinicaltrials.gov/api/v2/studies",
"rule": "A study counts as registrational when the registry says phase 3, the drug is named in its title or its interventions, and the sponsor is the company this record holds as owning the drug or its named partner. Expanded access programmes, long term follow ups, extensions and open label extensions are excluded by name, because the first pass matched exactly those.",
"why": "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.",
"none_found": [
{
"drug": "Fayuvi (rebisufligene etisparvovec-hopf)",
"status": "approved",
"why": "no registered study met the rule: phase 3, the drug named, the sponsor agreeing, and not an access or extension programme"
},
{
"drug": "Pixclara (floretyrosine F 18)",
"status": "approved",
"why": "no registered study met the rule: phase 3, the drug named, the sponsor agreeing, and not an access or extension programme"
},
{
"drug": "Rusfertide (Mimrylo)",
"status": "approved",
"why": "no registered study met the rule: phase 3, the drug named, the sponsor agreeing, and not an access or extension programme"
},
{
"drug": "BBP-418",
"status": "pending",
"why": "no registered study met the rule: phase 3, the drug named, the sponsor agreeing, and not an access or extension programme"
},
{
"drug": "Molgramostim",
"status": "pending",
"why": "no registered study met the rule: phase 3, the drug named, the sponsor agreeing, and not an access or extension programme"
},
{
"drug": "Zipalertinib",
"status": "pending",
"why": "no registered study met the rule: phase 3, the drug named, the sponsor agreeing, and not an access or extension programme"
}
],
"failures": []
},
"hindcast": {
"as_of": "2026-09-23",
"n": 8,
"right": 5,
"wrong": 3,
"on_fda_grounds": {
"right": 7,
"wrong": 1,
"what_changed": "A refusal is split on the grounds the FDA itself states in the letter. Clinical or statistical grounds, or an advisory committee voting against, stay impaired. A refusal raising only manufacturing or a third party facility inspection becomes cautioned, because the agency's own words in one of these letters are that the deficiencies may not be specific to the application.",
"and_why_it_is_not_evidence": "This rule was written after these nine outcomes were known and scored on the same nine. That is hindsight, and hindsight is not a result. What supports it independently is the FDA's own library: 309 of 458 published refusal letters are on applications that were later approved. What would test it is the 12 filings still awaiting a decision, and that test has not been run because those decisions have not happened.",
"the_one_it_still_gets_wrong": "Pixclara was refused on clinical grounds, which this rule still calls trouble, and it was approved 17 months later. An efficacy refusal is not fatal either."
},
"on_the_endpoint_signal": {
"right": 8,
"wrong": null,
"recent_right": 7,
"recent_n": 7,
"rule": "Call trouble 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. Everything else clears, including a refusal.",
"found_where": "It was found on 457 of the FDA's own published refusal letters, and THAT EVIDENCE IS WITHDRAWN. The corpus labels a letter approved or not according to whether the FDA had resolved it before publishing, so the rate measured the date on the letter. What is left supporting this rule is the FDA's stated grounds in each letter, a mechanism that can be said in a sentence, and nine names it was fitted on. That is a judgment, not a result.",
"honest_caveat": "Nothing here is out of sample. The rule was written after these nine outcomes were known, the corpus that appeared to support it does not, and no decision has yet been called with it before the fact."
},
"forward_test": {
"n": 13,
"names": [
"Anito-cel",
"BBP-418",
"Bezuclastinib",
"Bezuclastinib (AdvSM)",
"Bezuclastinib (NonAdvSM)",
"CagriSema",
"Deucrictibant IR",
"Lonvo-z",
"Lorundrostat",
"Molgramostim",
"Tinlarebant",
"Vosoritide (Voxzogo)",
"Zipalertinib"
],
"note": "The only honest test of a rule written today is the decisions that have not happened yet. These 13 filings carry a standing on the Odds view now, dated, and each will be right or wrong in public."
},
"naive_right": 8,
"recent": {
"n": 7,
"right": 4,
"naive_right": 7,
"from": "2026-01-01"
},
"by_tier": {
"clean": {
"n": 5,
"approved": 5
},
"impaired": {
"n": 3,
"approved": 3
}
},
"rows": [
{
"drug": "Icatibant (Firazyr)",
"id": "icatibant",
"company": "Jerini, acquired by Shire",
"decided_on": "2011-08-25",
"outcome": "approved",
"tier_as_at": "clean",
"call": "clears",
"right": true,
"tier_on_fda_grounds": "clean",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": []
},
{
"drug": "Orforglipron (Foundayo)",
"id": "orforglipron",
"company": "Eli Lilly",
"decided_on": "2026-04-01",
"outcome": "approved",
"tier_as_at": "clean",
"call": "clears",
"right": true,
"tier_on_fda_grounds": "clean",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": []
},
{
"drug": "Baxdrostat (Baxfendy)",
"id": "baxdrostat",
"company": "AstraZeneca",
"decided_on": "2026-05-15",
"outcome": "approved",
"tier_as_at": "clean",
"call": "clears",
"right": true,
"tier_on_fda_grounds": "clean",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": []
},
{
"drug": "Oveporexton (Orzeyful)",
"id": "oveporexton",
"company": "Takeda",
"decided_on": "2026-08-05",
"outcome": "approved",
"tier_as_at": "clean",
"call": "clears",
"right": true,
"tier_on_fda_grounds": "clean",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": []
},
{
"drug": "Rusfertide (Mimrylo)",
"id": "rusfertide",
"company": "Takeda and Protagonist Therapeutics",
"decided_on": "2026-08-28",
"outcome": "approved",
"tier_as_at": "clean",
"call": "clears",
"right": true,
"tier_on_fda_grounds": "clean",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": []
},
{
"drug": "Apitegromab (Isembyld)",
"id": "apitegromab",
"company": "Scholar Rock",
"decided_on": "2026-09-11",
"outcome": "approved",
"tier_as_at": "impaired",
"call": "trouble",
"right": false,
"tier_on_fda_grounds": "cautioned",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": [
{
"kind": "crl",
"date": "2025-09-22"
}
]
},
{
"drug": "Pixclara (floretyrosine F 18)",
"id": "pixclara",
"company": "Telix Pharmaceuticals",
"decided_on": "2026-09-11",
"outcome": "approved",
"tier_as_at": "impaired",
"call": "trouble",
"right": false,
"tier_on_fda_grounds": "impaired",
"call_on_fda_grounds": "trouble",
"right_on_fda_grounds": false,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": [
{
"kind": "crl",
"date": "2025-04-25"
}
]
},
{
"drug": "Fayuvi (rebisufligene etisparvovec-hopf)",
"id": "fayuvi",
"company": "Ultragenyx",
"decided_on": "2026-09-17",
"outcome": "approved",
"tier_as_at": "impaired",
"call": "trouble",
"right": false,
"tier_on_fda_grounds": "cautioned",
"call_on_fda_grounds": "clears",
"right_on_fda_grounds": true,
"call_on_endpoint": "clears",
"right_on_endpoint": true,
"evidence": [
{
"kind": "crl",
"date": "2025-07-07"
}
]
}
],
"every_error_is_the_same_error": "All 3 wrong calls are one mistake made 3 times: a complete response letter was read as a verdict. Each of those drugs had been refused, was placed in the impaired tier on the strength of it, and was then approved.",
"what_beats_it": "Saying yes to every filing would have been right 8 times out of 8. The standing call was right 5. On this sample the call is WORSE than assuming approval, and that is the number to look at rather than the accuracy on its own.",
"why_the_sample_is_like_this": "8 of the 8 decided names were approved. A screen of live filings does not accumulate refusals, because a refused drug leaves the board while an approved one is recorded as an outcome. So the base rate inside this sample sits far above the cohort rate for applications generally, which is 63% clearing a first cycle over the 2018 to 2022 PDUFA cycle, per advisory.avalerehealth.com read on 2026-09-23. Any accuracy figure here inherits that.",
"no_negatives": "Every settled outcome in this sample is an approval. There are no refusals in it at all, so it cannot measure whether a call discriminates: a sample with one class has no discrimination to measure. Saying yes to everything is right on every one of them, and that is a fact about the sample rather than about the FDA.",
"why_the_sample_has_no_negatives": "This board is a screen of LIVE FILINGS. A drug that is refused leaves the board and a drug that is approved is written down as an outcome, so the settled set accumulates approvals and sheds refusals. It is the same shape of fault as the FDA's letter corpus, arrived at from the opposite direction.",
"the_real_base_rate": "Across BLAs and NDAs generally, 37% received a complete response letter in the 2018 to 2022 cycle of Prescription Drug User Fees, per https://advisory.avalerehealth.com/insights/what-is-a-complete-response-letter read 2026-09-23. So roughly 63% clear a first cycle and saying yes to everything is wrong about one time in three. It is not 100%, and nothing here should be read as saying a refusal is rare.",
"not_a_rate": "Nine decisions is not a sample and none of these figures is a rate. They are a count of what would have happened, published because the count is what was asked for and because it does not flatter."
},
"signals": {
"checked": "2026-09-23",
"n": 457,
"approved": 309,
"naive_right": 309,
"base_rate_pct": 67.6,
"results": [
{
"signal": "the letter cites a failed primary endpoint",
"why": "The trial missed what it was designed to show.",
"flagged": {
"n": 27,
"approved": 11,
"rate": 0.4074074074074074
},
"rest": {
"n": 430,
"approved": 298,
"rate": 0.6930232558139535
},
"gap_points": 28.6,
"z": 3.08,
"right": 314,
"beats_naive": true,
"margin": 5,
"p": 0.0021,
"survives_multiplicity": true
},
{
"signal": "clinical grounds AND a new trial demanded",
"why": "The grounds say what is wrong and the remedy says how expensive it is.",
"flagged": {
"n": 21,
"approved": 10,
"rate": 0.47619047619047616
},
"rest": {
"n": 436,
"approved": 299,
"rate": 0.6857798165137615
},
"gap_points": 21.0,
"z": 2.0,
"right": 310,
"beats_naive": true,
"margin": 1,
"p": 0.0455,
"survives_multiplicity": false
},
{
"signal": "the letter raises clinical or statistical grounds",
"why": "The evidence itself did not carry, rather than the paperwork around it.",
"flagged": {
"n": 48,
"approved": 26,
"rate": 0.5416666666666666
},
"rest": {
"n": 409,
"approved": 283,
"rate": 0.6919315403422983
},
"gap_points": 15.0,
"z": 2.1,
"right": 305,
"beats_naive": false,
"margin": -4,
"p": 0.0357,
"survives_multiplicity": false
},
{
"signal": "the letter demands a new clinical trial",
"why": "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.",
"flagged": {
"n": 76,
"approved": 58,
"rate": 0.7631578947368421
},
"rest": {
"n": 381,
"approved": 251,
"rate": 0.6587926509186351
},
"gap_points": -10.4,
"z": -1.78,
"right": 269,
"beats_naive": false,
"margin": -40,
"p": 0.0751,
"survives_multiplicity": false
},
{
"signal": "the letter raises a facility inspection",
"why": "The agency's own words in one of these are that the deficiencies may not be specific to the application.",
"flagged": {
"n": 236,
"approved": 152,
"rate": 0.6440677966101694
},
"rest": {
"n": 221,
"approved": 157,
"rate": 0.7104072398190046
},
"gap_points": 6.6,
"z": 1.51,
"right": 241,
"beats_naive": false,
"margin": -68,
"p": 0.131,
"survives_multiplicity": false
},
{
"signal": "a second or later letter on the same application",
"why": "The first response did not satisfy the agency.",
"flagged": {
"n": 201,
"approved": 150,
"rate": 0.746268656716418
},
"rest": {
"n": 256,
"approved": 159,
"rate": 0.62109375
},
"gap_points": -12.5,
"z": -2.84,
"right": 210,
"beats_naive": false,
"margin": -99,
"p": 0.0045,
"survives_multiplicity": true
},
{
"signal": "the letter turns on safety",
"why": "A refusal about harm rather than about evidence.",
"flagged": {
"n": 382,
"approved": 257,
"rate": 0.6727748691099477
},
"rest": {
"n": 75,
"approved": 52,
"rate": 0.6933333333333334
},
"gap_points": 2.1,
"z": 0.35,
"right": 177,
"beats_naive": false,
"margin": -132,
"p": 0.7263,
"survives_multiplicity": false
}
],
"winners": [
"the letter cites a failed primary endpoint",
"clinical grounds AND a new trial demanded"
],
"candidates_tried": 7,
"bonferroni_alpha": 0.0071,
"multiplicity": "Seven candidates were tried, so reporting the best of them at the usual threshold is how a coincidence gets published. Correcting for having tried seven, the bar is p below 0.0071. TWO results clear it: the failed endpoint signal, and the second letter effect running backwards. The clinical grounds split does not, and is reported as suggestive rather than established.",
"verdict": "2 of 7 candidates beat assuming every refused application comes back.",
"what_accuracy_hides": "Accuracy is a poor test on a base rate of 68%, per https://api.fda.gov/transparency/crl.json read 2026-09-23. A signal can shift the odds by a wide margin and still lose a binary call, because flagging a case that comes back more often than not costs more than it saves. The separation between the arms is the useful number for anyone sizing a position rather than casting a vote."
},
"endpoint_signal": {
"checked": "2026-09-23",
"RETRACTED": "The corpus numbers below were published on 23 September 2026 and withdrawn the same day, source https://api.fda.gov/transparency/crl.json read 2026-09-23. They measure when a letter was written, not what became of the drug. The FDA publishes resolved archive cases, which are almost all approvals, alongside letters as it issues them, which have not resolved. 99.3% of letters dated up to 2023 read as approved and 0% of those dated 2025 or later do. The flagged letters average 2024.5 and 91% are dated 2024 or later. Inside one year the flag picks out a single letter. They are kept here rather than deleted so the retraction has something to point at.",
"pattern_plain": "the FDA wrote that the study failed to demonstrate efficacy, or did not meet its primary endpoint",
"corpus": {
"n": 457,
"naive_right": 309,
"base_rate_pct": 67.6,
"pre_registered": {
"flagged": 27,
"came_back_pct": 40.7,
"rest_pct": 69.3,
"z": 3.08,
"beats_naive_by": 5
},
"tightened": {
"flagged": 11,
"came_back_pct": 9.1,
"rest_pct": 69.1,
"z": 4.2,
"beats_naive_by": 9
},
"loosened": {
"flagged": 44,
"came_back_pct": 54.5,
"rest_pct": 69.0,
"z": 1.95,
"beats_naive_by": -4
},
"why_all_three_are_published": "The pre-registered pattern is the result. The tightened one was written after seeing it and is a refinement rather than a finding, so its number is labelled as such. The loosened one is there because it FAILS: diluting the phrase to any mention of something failing destroys the signal, which is what a real effect does and what an artefact of matching would not.",
"contamination": "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. Four of 457 is under one per cent of the corpus it was found in.",
"selection": "The FDA chooses which letters to publish, so 67.6% per https://api.fda.gov/transparency/crl.json read 2026-09-23 is a fact about the library rather than about refusals in general. The comparison is between two arms drawn from inside the same published set, which is why the contrast is reported and not the level."
}
},
"censoring": {
"checked": "2026-09-23",
"n": 457,
"by_year": {
"2002": {
"n": 1,
"approved": 1
},
"2004": {
"n": 1,
"approved": 1
},
"2007": {
"n": 1,
"approved": 1
},
"2008": {
"n": 1,
"approved": 1
},
"2009": {
"n": 2,
"approved": 2
},
"2010": {
"n": 2,
"approved": 2
},
"2011": {
"n": 2,
"approved": 2
},
"2012": {
"n": 4,
"approved": 4
},
"2013": {
"n": 12,
"approved": 12
},
"2014": {
"n": 8,
"approved": 8
},
"2015": {
"n": 9,
"approved": 9
},
"2016": {
"n": 20,
"approved": 20
},
"2017": {
"n": 25,
"approved": 25
},
"2018": {
"n": 33,
"approved": 33
},
"2019": {
"n": 38,
"approved": 37
},
"2020": {
"n": 35,
"approved": 35
},
"2021": {
"n": 48,
"approved": 48
},
"2022": {
"n": 25,
"approved": 25
},
"2023": {
"n": 30,
"approved": 29
},
"2024": {
"n": 69,
"approved": 14
},
"2025": {
"n": 59,
"approved": 0
},
"2026": {
"n": 32,
"approved": 0
}
},
"pre_2024": {
"n": 297,
"approved_pct": 99.3
},
"from_2025": {
"n": 91,
"approved_pct": 0.0
},
"the_signal_was_a_date": {
"flagged_mean_year": 2024.5,
"rest_mean_year": 2020.7,
"flagged_pct_2024_or_later": 91,
"rest_pct_2024_or_later": 34,
"within_2024": {
"flagged": 1,
"rest": 68,
"note": "one letter of sixty nine. Nothing is left to measure."
}
},
"what_it_rules_out": [
"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."
],
"conclusion": "No public, machine readable source holds FDA filings with both outcomes at scale, so a refusal predictor cannot be built honestly from public data and this room does not publish one.",
"what_was_retracted": "The signal published earlier on 23 September 2026, source https://api.fda.gov/transparency/crl.json read 2026-09-23: that letters citing a failed primary endpoint came back 9.1% of the time against 69.1% with z = 4.20, and the claim that it beat assuming everything comes back. It measured when the letter was written."
},
"profile": {
"checked": "2026-09-23",
"n": 528,
"base_pct": 76.9,
"grid": [
{
"profile": [],
"n": 528,
"pct": 76.9
},
{
"profile": [
"not a biologic"
],
"n": 400,
"pct": 79.8
},
{
"profile": [
"sponsor has prior approvals"
],
"n": 367,
"pct": 79.6
},
{
"profile": [
"priority review"
],
"n": 163,
"pct": 84.0
},
{
"profile": [
"not a biologic",
"sponsor has prior approvals"
],
"n": 280,
"pct": 82.1
},
{
"profile": [
"not a biologic",
"priority review"
],
"n": 115,
"pct": 87.0
},
{
"profile": [
"sponsor has prior approvals",
"priority review"
],
"n": 110,
"pct": 84.5
},
{
"profile": [
"not a biologic",
"sponsor has prior approvals",
"priority review"
],
"n": 74,
"pct": 87.8
}
],
"best": {
"profile": [
"not a biologic",
"sponsor has prior approvals",
"priority review"
],
"n": 74,
"pct": 87.8
},
"worst": {
"profile": [
"a biologic",
"first time sponsor"
],
"n": 41,
"pct": 61.0
},
"z_between_ends": 3.35,
"by_year": {
"2022": {
"n": 99,
"nda_pct": 72.4,
"bla_pct": 65.2
},
"2023": {
"n": 125,
"nda_pct": 73.5,
"bla_pct": 70.4
},
"2024": {
"n": 119,
"nda_pct": 79.3,
"bla_pct": 62.5
},
"2025": {
"n": 126,
"nda_pct": 83.7,
"bla_pct": 70.6
},
"2026": {
"n": 59,
"nda_pct": 97.9,
"bla_pct": 75.0
}
},
"window": [
2022,
2026
],
"window_why": "Before 2018 the FDA has published almost no letters, so an application approved then reads as having cleared first cycle whatever happened. Biologics also sit later on average than small molecules, mean approval year 2014.8 against 2006.3, so comparing the whole register lets composition masquerade as an effect. The raw split gave z = -6.27 and holding the year still gives +2.75. This window is where the corpus actually holds letters.",
"combinations_looked_at": 8,
"years_biologics_worse": 5,
"years_compared": 5,
"the_undercount": "The measured first cycle rate is 76.9%. The sourced rate for BLAs and NDAs generally is 63%, because 37% take a letter, per https://advisory.avalerehealth.com/insights/what-is-a-complete-response-letter read 2026-09-23. So roughly four in five letters issued are not in the published corpus and the applications holding them are counted here as having cleared. Every gap is diluted toward zero, so read each one as a floor.",
"the_survivors": "Drugs@FDA holds approved products, so an application that was refused and then abandoned is in neither class. This compares clearing first time against needing a second cycle, among drugs that got there in the end.",
"what_it_is_not": "Not a probability for any one filing, and not a claim that a biologic is a worse drug. It is a statement about how often each kind of application clears at the first attempt, and the mechanism is in the letters themselves: the refusals on this board that turned on manufacturing and facility inspection were all biologics."
},
"people": {
"rows": [
{
"id": "p_sec_0001253170",
"name": "Srinivas Akkaraju",
"role": "director",
"kind": "director",
"source_kind": "sec_ownership_filing",
"sec_cik": "0001253170",
"titles": [],
"is_director": true,
"is_officer": false,
"career": [
{
"issuer": "Graphite Bio, Inc.",
"since": "2021-06-24",
"title": null,
"as_director": false,
"as_officer": false
},
{
"issuer": "Scholar Rock Holding Corp",
"since": "2022-07-28",
"title": "",
"as_director": true,
"as_officer": false
},
{
"issuer": "Mineralys Therapeutics, Inc.",
"since": "2023-02-09",
"title": "",
"as_director": true,
"as_officer": false
},
{
"issuer": "CARGO Therapeutics, Inc.",
"since": "2023-11-09",
"title": null,
"as_director": false,
"as_officer": false
},
{
"issuer": "vTv Therapeutics Inc.",
"since": "2024-02-29",
"title": "",
"as_director": true,
"as_officer": false
},
{
"issuer": "ALUMIS INC.",
"since": "2024-06-27",
"title": "",
"as_director": true,
"as_officer": false
},
{
"issuer": "Neurogene Inc.",
"since": "2024-11-27",
"title": "",
"as_director": false,
"as_officer": false
},
{
"issuer": "Kalaris Therapeutics, Inc.",
"since": "2025-03-18",
"title": null,
"as_director": true,
"as_officer": false
}
],
"career_count": 8,
"career_truncated": true,
"career_src": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001253170&type=4",
"first_filed": "2021-06-24",
"affiliation": null,
"companies": [
{
"id": "mlys",
"label": "Mineralys",
"ticker": "MLYS",
"as_filed": "1",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001253170&type=4",
"drugs": [
{
"label": "Lorundrostat",
"status": "pending"
}
]
},
{
"id": "srrk",
"label": "Scholar Rock",
"ticker": "SRRK",
"as_filed": "1",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001253170&type=4",
"drugs": [
{
"label": "Apitegromab (Isembyld)",
"status": "approved"
}
]
}
],
"pending_here": 1,
"decisions": [
{
"drug": "Apitegromab (Isembyld)",
"kind": "approval",
"date": "2026-09-11"
},
{
"drug": "Apitegromab (Isembyld)",
"kind": "crl",
"date": "2025-09-22"
}
],
"trials": [],
"letters": []
},
{
"id": "p_sec_0001206199",
"name": "Daniel G Welch",
"role": "director",
"kind": "director",
"source_kind": "sec_ownership_filing",
"sec_cik": "0001206199",
"titles": [],
"is_director": true,
"is_officer": false,
"career": [
{
"issuer": "HYPERION THERAPEUTICS INC",
"since": "2012-08-28",
"title": null,
"as_director": true,
"as_officer": false
},
{
"issuer": "Corium International, Inc.",
"since": "2014-04-02",
"title": "",
"as_director": true,
"as_officer": false
},
{
"issuer": "Ultragenyx Pharmaceutical Inc.",
"since": "2015-04-10",
"title": null,
"as_director": true,
"as_officer": false
},
{
"issuer": "INTERCEPT PHARMACEUTICALS INC",
"since": "2015-11-27",
"title": "",
"as_director": true,
"as_officer": false
},
{
"issuer": "AveXis, Inc.",
"since": "2016-02-10",
"title": null,
"as_director": true,
"as_officer": false
},
{
"issuer": "Nuvation Bio Inc.",
"since": "2021-02-12",
"title": null,
"as_director": true,
"as_officer": false
},
{
"issuer": "Structure Therapeutics Inc.",
"since": "2023-02-02",
"title": null,
"as_director": true,
"as_officer": false
},
{
"issuer": "PROTHENA CORP PUBLIC LTD CO",
"since": "2024-02-23",
"title": null,
"as_director": true,
"as_officer": false
}
],
"career_count": 8,
"career_truncated": true,
"career_src": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001206199&type=4",
"first_filed": "2012-08-28",
"affiliation": null,
"companies": [
{
"id": "rare",
"label": "Ultragenyx",
"ticker": "RARE",
"as_filed": "true",
"url": "https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001206199&type=4",
"drugs": [
{
"label": "Fayuvi (rebisufligene etisparvovec-hopf)",
"status": "approved"
}
]
}
],
"pending_here": 0,
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"2027-03-19",
"2027-04-16",
"2027-07-16",
"2027-10-15",
"2027-12-17",
"2028-01-21"
],
"after": {
"expiry": "2027-01-15",
"days_past_decision": 24,
"strike": 25.0,
"straddle": 11.4,
"iv": 1.1685
},
"straddle_move_pct": 47.5,
"before": {
"expiry": "2026-12-18",
"days_before_decision": 4,
"strike": 25.0,
"straddle": 6.725,
"iv": 0.7451
},
"event_move_pct": 38.2,
"state": "read"
},
{
"filing": "molgramostim",
"drug": "Molgramostim",
"ticker": "SVRA",
"pdufa": "2026-11-22",
"precision": "day",
"spot": 4.89,
"quote_time": "2026-10-03 23:31:10",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/SVRA.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2027-02-19",
"2027-05-21"
],
"after": {
"expiry": "2027-02-19",
"days_past_decision": 89,
"strike": 6.0,
"straddle": 2.8,
"iv": 1.0184
},
"straddle_move_pct": 57.3,
"before": {
"expiry": "2026-11-20",
"days_before_decision": 2
},
"event_note": "the first expiry after the decision is 89 days later",
"note": "first expiry after the decision is 89 days later, so the straddle is mostly ordinary trading, not the decision",
"state": "read"
},
{
"filing": "bezuclastinib",
"drug": "Bezuclastinib",
"ticker": "COGT",
"pdufa": "2026-11-30",
"precision": "day",
"spot": 31.02,
"quote_time": "2026-10-03 23:27:30",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/COGT.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2027-01-15",
"2027-02-19",
"2027-05-21",
"2028-01-21"
],
"after": {
"expiry": "2027-01-15",
"days_past_decision": 46,
"strike": 32.0,
"straddle": 9.35,
"iv": 0.6964
},
"straddle_move_pct": 30.1,
"before": {
"expiry": "2026-11-20",
"days_before_decision": 10
},
"event_note": "the first expiry after the decision is 46 days later",
"note": "first expiry after the decision is 46 days later, so the straddle is mostly ordinary trading, not the decision",
"state": "read"
},
{
"filing": "cagrisema",
"drug": "CagriSema",
"ticker": "NVO",
"pdufa": "2026-Q4",
"precision": "quarter",
"spot": 37.32,
"quote_time": "2026-10-04 01:00:49",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/NVO.json",
"expiries": [
"2026-10-09",
"2026-10-16",
"2026-10-23",
"2026-10-30",
"2026-11-06",
"2026-11-13",
"2026-11-20",
"2026-12-18",
"2027-01-15",
"2027-03-19",
"2027-06-17",
"2027-09-17",
"2027-12-17",
"2028-01-21",
"2028-06-16",
"2028-12-15",
"2029-01-19"
],
"state": "decision dated to a quarter, not a day: no expiry can bracket it"
},
{
"filing": "zipalertinib",
"drug": "Zipalertinib",
"ticker": "CGEM",
"pdufa": "2027-02-27",
"precision": "day",
"spot": 15.51,
"quote_time": "2026-10-04 00:01:51",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/CGEM.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2026-12-18",
"2027-01-15",
"2027-03-19",
"2027-04-16",
"2027-06-17",
"2027-12-17"
],
"after": {
"expiry": "2027-03-19",
"days_past_decision": 20,
"strike": 15.0,
"straddle": 7.525,
"iv": 0.9371
},
"straddle_move_pct": 48.5,
"before": {
"expiry": "2027-01-15",
"days_before_decision": 43,
"strike": 16.0,
"straddle": 6.575,
"iv": 0.9893
},
"event_move_pct": null,
"event_note": "the expiry after the decision is priced no richer than the one before",
"state": "read"
},
{
"filing": "tinlarebant",
"drug": "Tinlarebant",
"ticker": "BLTE",
"pdufa": "2027-02-12",
"precision": "day",
"state": "no options chain returned (403): no listed options, or unread"
},
{
"filing": "lonvo_z",
"drug": "Lonvo-z",
"ticker": "NTLA",
"pdufa": "2027-03-10",
"precision": "day",
"spot": 12.278,
"quote_time": "2026-10-04 23:55:26",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/NTLA.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2027-01-15",
"2027-04-16",
"2028-01-21",
"2029-01-19"
],
"after": {
"expiry": "2027-04-16",
"days_past_decision": 37,
"strike": 12.0,
"straddle": 5.55,
"iv": 0.7933
},
"straddle_move_pct": 45.2,
"before": {
"expiry": "2027-01-15",
"days_before_decision": 54
},
"event_note": "the last expiry before the decision is 54 days earlier",
"state": "read"
},
{
"filing": "bbp_418",
"drug": "BBP-418",
"ticker": "BBIO",
"pdufa": "2026-11-27",
"precision": "day",
"spot": 67.25,
"quote_time": "2026-10-02 23:25:29",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/BBIO.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2027-01-15",
"2027-02-19",
"2027-03-19",
"2027-05-21",
"2027-08-20",
"2027-11-19",
"2028-01-21",
"2028-12-15",
"2029-01-19"
],
"after": {
"expiry": "2027-01-15",
"days_past_decision": 49,
"strike": 67.5,
"straddle": 13.55,
"iv": 0.4714
},
"straddle_move_pct": 20.1,
"before": {
"expiry": "2026-11-20",
"days_before_decision": 7
},
"event_note": "the first expiry after the decision is 49 days later",
"note": "first expiry after the decision is 49 days later, so the straddle is mostly ordinary trading, not the decision",
"state": "read"
},
{
"filing": "deucrictibant",
"drug": "Deucrictibant IR",
"ticker": "PHVS",
"pdufa": "2027-04-23",
"precision": "day",
"spot": 31.19,
"quote_time": "2026-10-03 23:46:00",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/PHVS.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2026-12-18",
"2027-01-15",
"2027-03-19",
"2027-12-17"
],
"after": {
"expiry": "2027-12-17",
"days_past_decision": 238,
"strike": 30.0,
"straddle": 18.0,
"iv": 0.6976
},
"straddle_move_pct": 57.7,
"before": {
"expiry": "2027-03-19",
"days_before_decision": 35
},
"event_note": "the first expiry after the decision is 238 days later",
"note": "first expiry after the decision is 238 days later, so the straddle is mostly ordinary trading, not the decision",
"state": "read"
},
{
"filing": "deramiocel",
"drug": "Deramiocel",
"ticker": "CAPR",
"pdufa": "2026-11-22",
"precision": "day",
"spot": 9.0254,
"quote_time": "2026-10-03 23:22:44",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/CAPR.json",
"expiries": [
"2026-10-09",
"2026-10-16",
"2026-10-23",
"2026-10-30",
"2026-11-06",
"2026-11-13",
"2026-11-20",
"2026-12-18",
"2027-01-15",
"2027-03-19",
"2028-01-21",
"2029-01-19"
],
"after": {
"expiry": "2026-12-18",
"days_past_decision": 26,
"strike": 9.0,
"straddle": 8.45,
"iv": 2.7074
},
"straddle_move_pct": 93.6,
"before": {
"expiry": "2026-11-20",
"days_before_decision": 2,
"strike": 9.0,
"straddle": 5.675,
"iv": 2.2116
},
"event_move_pct": 56.9,
"state": "read"
},
{
"filing": "anito_cel",
"drug": "Anito-cel",
"ticker": null,
"pdufa": "2026-12-23",
"precision": "day",
"state": "no US-listed equity quoted for this filing"
},
{
"filing": "bezuclastinib_nonadvsm",
"drug": "Bezuclastinib (NonAdvSM)",
"ticker": "COGT",
"pdufa": "2026-12-30",
"precision": "day",
"spot": 31.02,
"quote_time": "2026-10-03 23:27:30",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/COGT.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2027-01-15",
"2027-02-19",
"2027-05-21",
"2028-01-21"
],
"after": {
"expiry": "2027-01-15",
"days_past_decision": 16,
"strike": 32.0,
"straddle": 9.35,
"iv": 0.6964
},
"straddle_move_pct": 30.1,
"before": {
"expiry": "2026-11-20",
"days_before_decision": 40,
"strike": 31.0,
"straddle": 4.85,
"iv": 0.5331
},
"event_move_pct": 19.1,
"state": "read"
},
{
"filing": "bezuclastinib_advsm",
"drug": "Bezuclastinib (AdvSM)",
"ticker": "COGT",
"pdufa": "2027-06-29",
"precision": "day",
"spot": 31.02,
"quote_time": "2026-10-03 23:27:30",
"src": "https://cdn-api.cboe.com/api/global/delayed_quotes/options/COGT.json",
"expiries": [
"2026-10-16",
"2026-11-20",
"2027-01-15",
"2027-02-19",
"2027-05-21",
"2028-01-21"
],
"after": {
"expiry": "2028-01-21",
"days_past_decision": 206,
"strike": 32.0,
"straddle": 16.3,
"iv": 0.5879
},
"straddle_move_pct": 52.5,
"before": {
"expiry": "2027-05-21",
"days_before_decision": 39
},
"event_note": "the first expiry after the decision is 206 days later",
"note": "first expiry after the decision is 206 days later, so the straddle is mostly ordinary trading, not the decision",
"state": "read"
}
],
"basis": ", NEVER BLENDED.\n straddle the at-the-money straddle on the first expiry AFTER the decision, as a share of the\n price. It includes every ordinary trading day up to that expiry, not just the decision.\n event the move attributable to the decision alone, from the term structure: the variance of\n the first expiry after the decision minus what the expiry before it implies for the same\n span. Only computable when an expiry falls before the decision as well as after.\nA name with no listed options, or no expiry near its decision, is recorded as such, never as zero."
},
"cash": {
"read_at": "2026-10-05 00:39 UTC",
"source": "SEC XBRL company facts",
"rows": [
{
"ticker": "MLYS",
"cik": "0001933414",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001933414.json",
"standard": "us-gaap",
"as_of": "2026-06-30",
"tags": {
"InvestmentsAndCash": {
"value": 661400000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-11"
},
"CashAndCashEquivalentsAtCarryingValue": {
"value": 138268000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-11"
},
"CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents": {
"value": 138268000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-11"
}
},
"cash_and_investments": 661400000,
"basis": "the company's own total tag",
"unit": "USD",
"debt": 100000,
"debt_tags": {
"LongTermDebt": 100000
},
"net_cash": 661300000,
"burn": {
"end": "2025-06-30",
"quarter_ocf": -30169000,
"fy": 2026,
"fp": "Q2"
},
"runway_quarters": 21.9,
"shares": 88406885,
"shares_as_of": "2026-08-03",
"cash_per_share": 7.48,
"net_cash_per_share": 7.48,
"price": 23.63,
"cash_share_of_price_pct": 31.7,
"net_cash_share_of_price_pct": 31.7,
"age_days": 97,
"stale": false,
"state": "read"
},
{
"ticker": "PHVS",
"cik": "0001830487",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001830487.json",
"standard": "ifrs-full",
"as_of": "2025-12-31",
"tags": {
"CashAndCashEquivalents": {
"value": 291678888,
"unit": "EUR",
"form": "20-F",
"filed": "2026-04-02"
}
},
"cash_and_investments": 291678888,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "EUR",
"debt": 0,
"debt_tags": {},
"net_cash": 291678888,
"shares": 65210590,
"shares_as_of": "2025-12-31",
"age_days": 278,
"stale": true,
"state": "read"
},
{
"ticker": "COGT",
"cik": "0001622229",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001622229.json",
"standard": "us-gaap",
"as_of": "2026-06-30",
"tags": {
"CashAndCashEquivalentsAtCarryingValue": {
"value": 181172000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-10"
},
"CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents": {
"value": 181588000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-10"
},
"AvailableForSaleSecuritiesDebtSecuritiesCurrent": {
"value": 611128000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-10"
}
},
"cash_and_investments": 792300000,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "USD",
"debt": 223457000,
"debt_tags": {
"LongTermDebt": 223457000,
"ConvertibleDebtNoncurrent": 223457000
},
"net_cash": 568843000,
"burn": {
"end": "2025-06-30",
"quarter_ocf": -54542000,
"fy": 2026,
"fp": "Q2"
},
"runway_quarters": 14.5,
"shares": 173524982,
"shares_as_of": "2026-08-06",
"cash_per_share": 4.57,
"net_cash_per_share": 3.28,
"price": 31.02,
"cash_share_of_price_pct": 14.7,
"net_cash_share_of_price_pct": 10.6,
"age_days": 97,
"stale": false,
"state": "read"
},
{
"ticker": "BBIO",
"cik": "0001743881",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001743881.json",
"standard": "us-gaap",
"as_of": "2026-06-30",
"tags": {
"CashAndCashEquivalentsAtCarryingValue": {
"value": 677911000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-10"
},
"CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents": {
"value": 680036000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-10"
},
"AvailableForSaleSecuritiesDebtSecuritiesCurrent": {
"value": 42249000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-10"
}
},
"cash_and_investments": 720160000,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "USD",
"debt": 2652873000,
"debt_tags": {
"LongTermDebt": 2652873000
},
"net_cash": -1932713000,
"burn": {
"end": "2025-06-30",
"quarter_ocf": -80681000,
"fy": 2026,
"fp": "Q2"
},
"runway_quarters": 8.9,
"shares": 195487474,
"shares_as_of": "2026-08-03",
"cash_per_share": 3.68,
"net_cash_per_share": -9.89,
"price": 67.25,
"cash_share_of_price_pct": 5.5,
"net_cash_share_of_price_pct": -14.7,
"age_days": 97,
"stale": false,
"state": "read"
},
{
"ticker": "BMRN",
"cik": "0001048477",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001048477.json",
"standard": "us-gaap",
"as_of": "2026-06-30",
"tags": {
"CashAndCashEquivalentsAtCarryingValue": {
"value": 874005000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
},
"CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents": {
"value": 874005000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
},
"AvailableForSaleSecuritiesDebtSecuritiesCurrent": {
"value": 0,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
},
"AvailableForSaleSecuritiesDebtSecuritiesNoncurrent": {
"value": 0,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
}
},
"cash_and_investments": 874005000,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "USD",
"debt": 4186142000,
"debt_tags": {
"LongTermDebt": 4186142000,
"LongTermDebtNoncurrent": 3527939000,
"LongTermDebtCurrent": 658203000
},
"net_cash": -3312137000,
"burn": {
"end": "2025-06-30",
"quarter_ocf": 185271000,
"fy": 2026,
"fp": "Q2"
},
"shares": 193573759,
"shares_as_of": "2026-07-28",
"cash_per_share": 4.52,
"net_cash_per_share": -17.11,
"price": 57.18,
"cash_share_of_price_pct": 7.9,
"net_cash_share_of_price_pct": -29.9,
"age_days": 97,
"stale": false,
"state": "read"
},
{
"ticker": "BLTE",
"cik": "0001889109",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001889109.json",
"standard": "us-gaap",
"as_of": "2025-12-31",
"tags": {
"CashAndCashEquivalentsAtCarryingValue": {
"value": 352932000,
"unit": "USD",
"form": "20-F",
"filed": "2026-03-31"
},
"CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents": {
"value": 352932000,
"unit": "USD",
"form": "20-F",
"filed": "2026-03-31"
}
},
"cash_and_investments": 352932000,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "USD",
"debt": 0,
"debt_tags": {},
"net_cash": 352932000,
"shares": 39339960,
"shares_as_of": "2025-12-31",
"cash_per_share": 8.97,
"net_cash_per_share": 8.97,
"price": 159.56,
"cash_share_of_price_pct": 5.6,
"net_cash_share_of_price_pct": 5.6,
"age_days": 278,
"stale": true,
"state": "read"
},
{
"ticker": "CGEM",
"cik": "0001789972",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001789972.json",
"standard": "us-gaap",
"as_of": "2026-06-30",
"tags": {
"CashCashEquivalentsAndShortTermInvestments": {
"value": 334500000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
},
"CashAndCashEquivalentsAtCarryingValue": {
"value": 78640000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
},
"ShortTermInvestments": {
"value": 255898000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
},
"LongTermInvestments": {
"value": 19020000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-06"
}
},
"cash_and_investments": 353558000,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "USD",
"debt": 0,
"debt_tags": {},
"net_cash": 353558000,
"burn": {
"end": "2025-06-30",
"quarter_ocf": -57609000,
"fy": 2026,
"fp": "Q2"
},
"runway_quarters": 6.1,
"shares": 64354694,
"shares_as_of": "2026-07-31",
"cash_per_share": 5.49,
"net_cash_per_share": 5.49,
"price": 15.51,
"cash_share_of_price_pct": 35.4,
"net_cash_share_of_price_pct": 35.4,
"age_days": 97,
"stale": false,
"state": "read"
},
{
"ticker": "SVRA",
"cik": "0001160308",
"src": "https://data.sec.gov/api/xbrl/companyfacts/CIK0001160308.json",
"standard": "us-gaap",
"as_of": "2026-06-30",
"tags": {
"CashAndCashEquivalentsAtCarryingValue": {
"value": 41800000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-11"
},
"ShortTermInvestments": {
"value": 131234000,
"unit": "USD",
"form": "10-Q",
"filed": "2026-08-11"
}
},
"cash_and_investments": 173034000,
"basis": "cash plus the investment tags it reports at the same date",
"unit": "USD",
"debt": 30109000,
"debt_tags": {
"LongTermDebt": 30109000,
"LongTermDebtNoncurrent": 30109000,
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{
"company": "Jade Biosciences, Inc.",
"ticker": "JBIO",
"cik": "0001798749",
"pdufa": "2026-11-30",
"sentence": "The FDA has also accepted a Biologics License Application for accelerated approval of povetacicept in IgAN, with a Prescription Drug User Fee Act target action date of November 30, 2026.",
"filed": "2026-08-10",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/1798749/000119312526341242/ck0001798749-20260630.htm",
"on_board": false
},
{
"company": "Zai Lab Ltd",
"ticker": "ZLAB",
"cik": "0001704292",
"pdufa": "2026-11-30",
"sentence": "• Povetacicept (pove, APRIL/BAFF): In June 2026, Zai Lab partner Vertex announced that the FDA accepted its BLA submission for pove for accelerated approval in adults with immunoglobulin A nephropathy (IgAN), with a PDUFA target action date of November 30, 2026.",
"filed": "2026-08-06",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htm",
"on_board": false
},
{
"company": "VERTEX PHARMACEUTICALS INC / MA",
"ticker": "VRTX",
"cik": "0000875320",
"pdufa": "2026-11-30",
"sentence": "• The FDA accepted our biologics license application for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.",
"filed": "2026-08-04",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/875320/000087532026000259/vrtx-20260630.htm",
"on_board": false
},
{
"company": "EXELIXIS, INC.",
"ticker": "EXEL",
"cik": "0000939767",
"pdufa": "2026-12-03",
"sentence": "The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.",
"filed": "2026-08-05",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm",
"on_board": false
},
{
"company": "Vanda Pharmaceuticals Inc.",
"ticker": "VNDA",
"cik": "0001347178",
"pdufa": "2026-12-12",
"sentence": "Other Updates • The Biologics License Application (BLA) for Quimilza TM in GPP is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.",
"filed": "2026-08-06",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/1347178/000162828026053855/vnda-20260630.htm",
"on_board": false
},
{
"company": "ANAPTYSBIO, INC",
"ticker": "ANAB",
"cik": "0001370053",
"pdufa": "2026-12-12",
"sentence": "The FDA accepted the BLA filing for imsidolimab in GPP in February 2026 with a target action date of December 12, 2026.",
"filed": "2026-05-12",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/1370053/000119312526219515/anab-20260331.htm",
"on_board": false
},
{
"company": "CORCEPT THERAPEUTICS INC",
"ticker": "CORT",
"cik": "0001088856",
"pdufa": "2026-12-17",
"sentence": "Hypercortisolism (Cushing’s Syndrome) • Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026 • GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026) • CATALYST and MOMENTUM – New data presented at American Diabetes Association’s (ADA) 86 th Scientific Ses",
"filed": "2026-07-29",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1088856/000162828026050607/cort072926ex991pressrelease.htm",
"on_board": false
},
{
"company": "Mineralys Therapeutics, Inc.",
"ticker": "MLYS",
"cik": "0001933414",
"pdufa": "2026-12-22",
"sentence": "EX-99.1 2 mlys202603068kex991.htm EX-99.1 Document Exhibit 99.1 Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results – The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension – – Topline results from the Phase 2 Explore-OSA explora",
"filed": "2026-03-09",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/mlys202603068kex991.htm",
"on_board": true
},
{
"company": "GILEAD SCIENCES, INC.",
"ticker": "GILD",
"cik": "0000882095",
"pdufa": "2026-12-23",
"sentence": "• Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.",
"filed": "2026-08-06",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/882095/000088209526000031/gild-20260630.htm",
"on_board": false
},
{
"company": "Praxis Precision Medicines, Inc.",
"ticker": "PRAX",
"cik": "0001689548",
"pdufa": "2026-12-27",
"sentence": "PDUFA date of December 27, 2026 FDA Bioresearch Monitoring (BIMO) inspections of Praxis for both ulixacaltamide and relutrigine completed with no Form FDA 483 observations Commercial infrastructure build-out accelerating for ulixacaltamide HCl in Essential Tremor and relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) ahead of expected approvals Praxis received its third Breakthrough Therapy Designation following the positive results from the EMBRAVE Part A trial o",
"filed": "2026-08-06",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm",
"on_board": false
},
{
"company": "Viatris Inc",
"ticker": "VTRS",
"cik": "0001792044",
"pdufa": "2026-12-27",
"sentence": "The FDA has assigned a PDUFA goal date of December 27, 2026.",
"filed": "2026-08-06",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1792044/000179204426000037/exhibit991-2q26earningsrel.htm",
"on_board": false
},
{
"company": "Cogent Biosciences, Inc.",
"ticker": "COGT",
"cik": "0001622229",
"pdufa": "2026-12-30",
"sentence": "The FDA assigned a Prescription Drug User Fee Act (\"PDUFA\") target action date of December 30, 2026.",
"filed": "2026-08-10",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/1622229/000119312526342393/cogt-20260630.htm",
"on_board": true
},
{
"company": "Nuvation Bio Inc.",
"ticker": "NUVB",
"cik": "0001811063",
"pdufa": "2027-01-04",
"sentence": "Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027.",
"filed": "2026-08-06",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1811063/000119312526336751/d261840dex991.htm",
"on_board": false
},
{
"company": "ImmunityBio, Inc.",
"ticker": "IBRX",
"cik": "0001326110",
"pdufa": "2027-01-06",
"sentence": "urologists and strong market access • First-half 2026 net product revenue of $94.8 million, up 121% compared with the first-half of 2025 • In July 2026, we announced the Emirates Drug Establishment of the United Arab Emirates granted the broadest marketing authorization for ANKTIVA across BCG-unresponsive NMIBC for CIS and papillary disease and metastatic NSCLC • The FDA accepted for review the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA plus BCG in patients with BCG-",
"filed": "2026-08-04",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1326110/000132611026000077/ibrx-202684x8kexhibit991.htm",
"on_board": false
},
{
"company": "Dyne Therapeutics, Inc.",
"ticker": "DYN",
"cik": "0001818794",
"pdufa": "2027-01-21",
"sentence": "PDUFA target action date set for January 21, 2027 - - Completed enrollment of 71 participants in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in DM1;",
"filed": "2026-07-29",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htm",
"on_board": false
},
{
"company": "Praxis Precision Medicines, Inc.",
"ticker": "PRAX",
"cik": "0001689548",
"pdufa": "2027-01-29",
"sentence": "PDUFA date of January 29, 2027 Mid-cycle meeting completed for relutrigine;",
"filed": "2026-08-06",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm",
"on_board": false
},
{
"company": "Pharming Group N.V.",
"ticker": "PHAR",
"cik": "0001828316",
"pdufa": "2027-01-30",
"sentence": "FDA acceptance and Priority Review of sNDA for lower doses of Joenja® to treat children with APDS • If approved, Joenja would be available to eligible patients aged 4 years and older with APDS who weigh 13 kg or more • Decision follows recent approval of Joenja for children aged 4 to 11 years with APDS weighing at least 27 kg • PDUFA target action date of January 30, 2027 Leiden, the Netherlands, September 25, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology compan",
"filed": "2026-09-25",
"form": "6-K",
"src": "https://www.sec.gov/Archives/edgar/data/1828316/000182831626000041/pharmingannouncesusfdaacce.htm",
"on_board": false
},
{
"company": "GILEAD SCIENCES, INC.",
"ticker": "GILD",
"cik": "0000882095",
"pdufa": "2027-02-02",
"sentence": "Food and Drug Administration (“FDA”) accepted a supplemental New Drug Application (“NDA”) submission for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis, with a Prescription Drug User Fee Act (“PDUFA”) target action date of February 2, 2027.",
"filed": "2026-08-06",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/882095/000088209526000031/gild-20260630.htm",
"on_board": false
},
{
"company": "BELITE BIO, INC",
"ticker": "BLTE",
"cik": "0001889109",
"pdufa": "2027-02-12",
"sentence": "Prescription Drug User Fee Act target action date of February 12, 2027 · If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 and could become the first Sakigake pharmaceutical product for ophthalmology disease in Japan SAN DIEGO, Sept.",
"filed": "2026-09-08",
"form": "6-K",
"src": "https://www.sec.gov/Archives/edgar/data/1889109/000110465926105608/tm2624806d1_ex99-1.htm",
"on_board": true
},
{
"company": "Arcutis Biotherapeutics, Inc.",
"ticker": "ARQT",
"cik": "0001787306",
"pdufa": "2027-02-23",
"sentence": "EX-99.1 2 pressreleaseex991q22026.htm EX-99.1 Document Arcutis Announces Second Quarter 2026 Financial Results and Provides Business Update • Continued strong ZORYVE® (roflumilast) net product revenue growth, with Q2 revenues of $129.9 million, +59% versus Q2 of 2025, and +23% versus Q1 of 2026, driven primarily by strong demand growth • Company raising 2026 full-year net product sales guidance to $525 million–$540 million • Received approval to expand the indication for ZORYVE cream 0.3% for th",
"filed": "2026-08-05",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htm",
"on_board": false
},
{
"company": "Cullinan Therapeutics, Inc.",
"ticker": "CGEM",
"cik": "0001789972",
"pdufa": "2027-02-27",
"sentence": "An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.",
"filed": "2026-10-02",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-ex99_1.htm",
"on_board": true
},
{
"company": "ArriVent BioPharma, Inc.",
"ticker": "AVBP",
"cik": "0001868279",
"pdufa": "2027-02-27",
"sentence": "In January 2025, Taiho Therapeutics and Cullinan Therapeutics announced that their study of the oral EGFR inhibitor zipalertinib met the primary endpoint in a Phase 2b clinical trial of patients in second or later line NSCLC patients with EGFR exon 20 insertion mutations and in April 2026 announced a February 27, 2027 Prescription Drug User Fee Act (“PDUFA”) target action date for the New Drug Application (“NDA”) filed for that indication.",
"filed": "2026-08-12",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/1868279/000110465926094902/avbp-20260630x10q.htm",
"on_board": false
},
{
"company": "Apnimed, Inc.",
"ticker": "APMD",
"cik": "0001745648",
"pdufa": "2027-02-28",
"sentence": "Food and Drug Administration (“FDA”) Accepted the NDA for AD109, with a proposed proprietary name Oxnimbi ™, and assigned a PDUFA target action date of February 28, 2027 • If approved, Oxnimbi has the potential to become the first oral pharmacologic therapy designed to address the neuromuscular root cause of upper airway collapse for the millions of people living with OSA • Strengthened the Company’s leadership team with several key appointments • Completed its upsized initial public offering fo",
"filed": "2026-09-08",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htm",
"on_board": false
},
{
"company": "BIOMARIN PHARMACEUTICAL INC",
"ticker": "BMRN",
"cik": "0001048477",
"pdufa": "2027-02-28",
"sentence": "• In July, BioMarin announced that the FDA accepted its sNDA for full approval of VOXZOGO in children with achondroplasia, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.",
"filed": "2026-08-06",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1048477/000104847726000015/earningsrelease-6aug26ex991.htm",
"on_board": true
},
{
"company": "Intellia Therapeutics, Inc.",
"ticker": "NTLA",
"cik": "0001652130",
"pdufa": "2027-03-10",
"sentence": "Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for lonvoguran ziclumeran (“lonvo-z”) and granted the BLA Priority Review with a Prescription Drug User Fee Act (“PDUFA”) target action date of March 10, 2027.",
"filed": "2026-09-08",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htm",
"on_board": true
},
{
"company": "BRISTOL MYERS SQUIBB CO",
"ticker": "BMY",
"cik": "0000014272",
"pdufa": "2027-03-11",
"sentence": "The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027.",
"filed": "2026-07-30",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htm",
"on_board": false
},
{
"company": "Harmony Biosciences Holdings, Inc.",
"ticker": "HRMY",
"cik": "0001802665",
"pdufa": "2027-04-01",
"sentence": "Target PDUFA Date April 1, 2027 Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028 Conference Call and Webcast Today at 8:30 a.m.",
"filed": "2026-08-04",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d1.htm",
"on_board": false
},
{
"company": "Inhibrx Biosciences, Inc.",
"ticker": "INBX",
"cik": "0002007919",
"pdufa": "2027-04-14",
"sentence": "Food and Drug Administration (FDA) accepted for filing the Company’s biologics license application (BLA) for the potential approval of ozekibart in conventional chondrosarcoma and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027.",
"filed": "2026-08-13",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/2007919/000200791926000044/exhibit99106302026.htm",
"on_board": false
},
{
"company": "Pharvaris N.V.",
"ticker": "PHVS",
"cik": "0001830487",
"pdufa": "2027-04-23",
"sentence": "Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027.",
"filed": "2026-08-12",
"form": "6-K",
"src": "https://www.sec.gov/Archives/edgar/data/1830487/000119312526345702/phvs-ex99_2.htm",
"on_board": true
},
{
"company": "Royalty Pharma plc",
"ticker": "RPRX",
"cik": "0001802768",
"pdufa": "2027-04-23",
"sentence": "deucrictibant In July 2026, Pharvaris announced that the FDA accepted its NDA for deucrictibant immediate-release for the on-demand treatment of hereditary angioedema attacks and assigned a PDUFA date of April 23, 2027.",
"filed": "2026-08-05",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htm",
"on_board": false
},
{
"company": "Organogenesis Holdings Inc.",
"ticker": "ORGO",
"cik": "0001661181",
"pdufa": "2027-04-24",
"sentence": "During June 2026, the FDA accepted the BLA for review and assigned a PDUFA target action date of April 24, 2027.",
"filed": "2026-08-06",
"form": "10-Q",
"src": "https://www.sec.gov/Archives/edgar/data/1661181/000119312526338049/orgo-20260630.htm",
"on_board": false
},
{
"company": "Immunome Inc.",
"ticker": "IMNM",
"cik": "0001472012",
"pdufa": "2027-04-28",
"sentence": "EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Reports Second Quarter 2026 Financial Results and Provides Business Update August 11, 2026 • Varegacestat PDUFA target action date set for April 28, 2027, following U.S.",
"filed": "2026-08-11",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htm",
"on_board": false
},
{
"company": "Axsome Therapeutics, Inc.",
"ticker": "AXSM",
"cik": "0001579428",
"pdufa": "2027-05-01",
"sentence": "EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update Total 2Q 2026 net product revenue of $218.4 million, representing 46% year-over-year growth AUVELITY ® 2Q 2026 net product sales of $180.3 million, representing 51% year-over-year growth SUNOSI ® 2Q 2026 net product revenue of $35.8 million, representing 20% year-over-year growth SYMBRAVO ® 2Q 2026 net product sales of $2.3 million AUVELITY launche",
"filed": "2026-08-10",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htm",
"on_board": false
},
{
"company": "BridgeBio Pharma, Inc.",
"ticker": "BBIO",
"cik": "0001743881",
"pdufa": "2027-05-07",
"sentence": "encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027);",
"filed": "2026-08-31",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htm",
"on_board": true
},
{
"company": "BridgeBio Pharma, Inc.",
"ticker": "BBIO",
"cik": "0001743881",
"pdufa": "2027-05-08",
"sentence": "encaleret for ADH1 was accepted with Priority Review (PDUFA May 8, 2027), with no advisory committee planned for either;",
"filed": "2026-08-10",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm",
"on_board": true
},
{
"company": "BRISTOL MYERS SQUIBB CO",
"ticker": "BMY",
"cik": "0000014272",
"pdufa": "2027-05-13",
"sentence": "mezigdomide July 13 The FDA accepted a New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM), granting a PDUFA date of May 13, 2027.",
"filed": "2026-07-30",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htm",
"on_board": false
},
{
"company": "Zenas BioPharma, Inc.",
"ticker": "ZBIO",
"cik": "0001953926",
"pdufa": "2027-05-27",
"sentence": "PDUFA target action date of May 27, 2027 - - New study data confirm bioequivalence of obexelimab single-dose prefilled autoinjector pen compared to prefilled syringes - - Obexelimab global Phase 2 SunStone SLE trial topline results expected in Q4 2026 - - ZB021 (oral IL-17AA/AF inhibitor) dosing ongoing in Phase 1 trial;",
"filed": "2026-08-13",
"form": "8-K",
"src": "https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htm",
"on_board": false
}
],
"note": "a candidate list from companies' own filings; nothing here is on the board until researched"
}
},
"findings": [
{
"id": "f_fayuvi",
"title": "A complete response letter is not a verdict, and three of four on this board prove it",
"kind": "mechanism",
"sev": "high",
"body": "Ultragenyx filed UX111 for accelerated approval, took a complete response letter in July 2025, went away, and came back to win STANDARD FULL approval on 17 September 2026, two days before its target date. Full approval is a higher bar than the accelerated pathway originally sought, on a 23.5 point higher Bayley-III cognitive score over natural history, p<0.0001. It is the first ever treatment for its indication. It is not the exception: of the four refusals on this board whose FDA letter is published, three were approved afterwards, and the one that was not is the one whose letter says the registrational trial failed its primary endpoint. A resolved refusal is evidence of execution and an unresolved one is evidence of a problem, and this record tells them apart because every event is typed and dated.",
"evidence": [
"fayuvi",
"rare",
"ev_ux111_crl",
"ev_ux111_appr",
"transpher_a",
"mps_iiia"
],
"src": "drugs_fayuvi_html"
},
{
"id": "f_hae",
"title": "The same indication was read as a split one week and a genuine overlap the next",
"kind": "self-correction",
"sev": "high",
"body": "On 17 September this record read hereditary angioedema as a crowded indication that was not really a contest: deucrictibant treated an attack on demand, lonvo-z was a one time prophylactic, so the collision was a split. Pharvaris then reported CHAPTER-3, which puts deucrictibant XR into prophylaxis, and the reading inverted. The indication now carries 4 drugs (Deucrictibant IR, Deucrictibant XR, Icatibant (Firazyr), Lonvo-z) and Pharvaris is competing against Intellia with its own second asset. Nothing was corrected here, because nothing was wrong: the world moved and the record moved with it, one week apart, both states dated. That is what the as-of on every claim is for.",
"evidence": [
"hae",
"deucrictibant",
"deucrictibant_xr",
"lonvo_z",
"icatibant",
"chapter3",
"phvs",
"ntla"
],
"src": "ir_pharvaris_announces_positive_topline_d_2"
},
{
"id": "f_adverse",
"title": "Every pending name carrying a refusal is one query, not a reading exercise",
"kind": "traversal",
"sev": "medium",
"body": "Regulatory events are typed, so adverse history is a class and not a judgment call. 7 drugs carry at least one adverse event between them: Apitegromab (Isembyld) (Complete response letter); Deramiocel (Complete response letter, PDUFA extended, indication narrowed, Advisory committee voted 9 to 3 against); Fayuvi (rebisufligene etisparvovec-hopf) (Complete response letter); Lonvo-z (FDA request for preclinical fetal data); Molgramostim (Refuse to File, insufficient CMC, PDUFA extended 3 months, major amendment); Pixclara (floretyrosine F 18) (Complete response letter); Zipalertinib (REZILIENT3 reported 3 deaths from septic shock). Building the scorer forced a taxonomy fault into the open. One label, adcom_declined, was carrying both “the FDA is not planning an advisory committee”, which is favourable and removes panel risk, and “the advisory committee voted 9 to 3 against”, which is the opposite. Scoring those alike would have been wrong in both directions at once. The taxonomy now separates them, and a trial safety signal is distinguished from a request by the regulator, because the actor is different.",
"evidence": [
"deramiocel",
"molgramostim",
"lonvo_z",
"zipalertinib",
"ev_capr_adcom",
"ev_svra_rtf"
],
"src": "biopharmadive_826465"
},
{
"id": "f_closed_loop",
"title": "Two people connect an approved drug to a pending one, and we searched 280 to find them",
"kind": "traversal",
"sev": "medium",
"body": "The query asks for a person who shipped an approved drug where that drug is the regulatory precedent for a drug now pending. It returns 4 rows from 2 people. Berndt Modig and Jochen Knolle both connect to icatibant, and icatibant is precedent for both Pharvaris assets. Knolle is named as an inventor on icatibant and ran R&D at Jerini; Modig was its chief financial officer through the 2005 listing and the 2008 sale to Shire. THE SCOPE MATTERS AND WE STATE IT: this record holds 280 named executives, and the other 278 (Adam Scott Levy, Adrienne S Brown, Agosti Marcello Pignagnoli, Akshay Vaishnaw, Alexander Hardy, Alexander M Gold, Ali Behbahani, Ali J. Satvat, Amrit Ray, Anat Hakim, Andrea Ellis, Andrew Lo, Andrew R Allen, Andrew R Robbins, Andrew Stewart Plump, Anna Nijdam, Anne Erickson, Anne Lesage, Anne-Marie Martin, Anthony A. Florence Jr., Anthony Bergmann, Anthony Rosenberg, Arlene Morris, Arturo Molina MD, Asif Ali, Asuka Miyabashira, Athena Countouriotis, Awny Samaan Botros Farajallah, Barbara W. Bodem, Berndt Modig, Betty D Larson, Birgit C Schultes, Braden C. Parker, Brian Foard, Brian Goff, Brian Mueller, Brian Taylor Slingsby, Bruce D Broussard, Bruce Trapnell, MD, Bryan Giraudo, Carmen Chang, Caroline Litchfield, Caryn Parlavecchio, Charles Greg Guyer, Charles J Homcy, Chirfi Guindo, Christian Behrenbruch, Christine E Seidman, Christophe Pierre Weber, Christopher W. Cain, Cole Pinnow, Corazon (Corsee) D. Sanders, Corrine Savill, Craig McDonald, MD, Cristin Hubbard, Dalton E. Smart III, Daniel G Welch, Daniel Skovronsky, Daphne Karydas, Darren Charlton Smith, Darren Joel Patti, David A Ramsay, David A Ricks, David B Musket, David D. Meek, David E I Pyott, David Hallal, David L Lowrance, David Lebwohl, David Malcom Rodman, David Michael Williams, David N Gill, David Norman Cade, David P. Ryan, David R. Maraldo, David W. Nassif, Dean Y Li, Deborah Dunsire, Dennis Karl Huang, Derek DiRocco, Dinesh V PH D Patel, Diogo Rau, Donald A Zakrowski, Douglas A. Dachille, Douglas M Baker JR, Earl M Collier JR, Edgardo Hernandez, Edward J Dulac III, Edward T Mathers, Elaine J Heron, Elaine Mary Shannon, Eliana Clark, Elisabeth Bjork, Elizabeth M Anderson, Emiko Higashi, Emil D Kakkis, Eric Aguiar, Eric Crombez, Eric Dozier, Eric Warren, Erik Harris, Erin Burkhart, Es-Johansson An van, Evan Kearns, Forest Baskett, Frank Litvack, Frank Mccormick, Frank Verwiel, Fred E Cohen, Fred Hassan, Gabriele Ricci, Gabrielle Sulzberger, Gary Clark Biddle, Gaurav K Gupta, George Eric Davis, George W Dunbar JR, Georgia Keresty, Giles Richard Platford, Glenn Sblendorio, Gregory R Friberg, Hannah Valantine, Hao-Yuan Chuang, Harold E Selick, Hendrik Peter Scholl, Henry J Fuchs, Howard Horn, Ian T Clark, Ilya Yuffa, Inge G Thulin, Ita Lu, J Erik Fyrwald, Jacquelyn L Sumer, Jad Adaimi, James Basta, James C Momtazee, James J. Ferguson III, Jann Elizabeth Skinner, Jean Luc Butel, Jeffrey Alan Jones, Jeffrey S. Flier, Jennifer E. Cook, Jennifer Marie Smoter, Jennifer Michaelson, Jennifer Zachary, Jesse Goodman, Jessica Sachs, Jing L. Marantz, Johannes Gerardus Christiaan Petrus Schikan, Johannes Jacobus Oosthuizen, John Edward Robinson, John L. Green, John Leonard, John M Leonard, John Maraganore, John Michael Longo, John Richard Pinion, Jon Congleton, Jon Congleton, Joseph S McCracken, Joshua Reed, Juan R Luciano, Julie So-Young Kim, Junlin Ho, Karah Herdman Parschauer, Karen Jean Ferrante, Karen Krasney, Karimah Es Sabar, Kathleen R. McCabe, Kathy J Warden, Katie Peng, Keith Woods, Kenneth L. Custer, Kimberly A. Reed, Koichiro Kimura, Koji Hatsukawa, Kristina Burow, Lara Haddad RPh, RAC, Lauren Rusckowski Duprey, Lewis T Williams, Linda Marban, Lucas Montarce, Mani Sharma, Margaret Kayo, PhD, MBA, Maria Rivas, Maricel Apuli, Marie Elizabeth McDonald, Mark Alexander Nelson, Mark Awadalla, Mark J Enyedy, Mary Ellen Coe, Mary Kay Fenton, Mary Thistle, Masami Iijima, Matt Pauls, Matthew K Fust, Matthew Pauls, Matthew Ros, Maykin Ho, Melissa Seymour, Michael Gilman, Michael Narachi, Michael P Dube, Michael T Maurer, Michel Bruno Orsinger, Mike Kelliher, Miki Tsusaka, Milano Furuta, Mittie Doyle, Mo Qatanani, Mohamad Makhzoumi, Muna Bhanji, Naarden Jacob Van, Nadim Ahmed, Nadim Ahmed, Natalie Anne Marie Furney, Nathan L. Mata, Neda Aghajani Memar, Neil Kumar, Nevan C Elam, Nicola Deidre Petal Greenway, Pamela J. Craig, Patricia F Russo, Patrik Jonsson, Paul Edward Walker, Paul Gisbert Auwaerter, Paul Rothman, Paulus Stoffels, Peng Lu, Peter Evan Harwin, Philip J Gotwals, Rachael Easton, MD, Ph.D., Ralph Alvarez, Ramy Riad Ahmed Ibrahim, Randal W. Scott, Rashmi Virendra Ramchandani, Raymond Dennis Pratt, Rhonda Janice Pacheco, Richard A Meier, Richard Brudnick, Richard J Hawkins, Richard R. DeLuca, Rick Yang, Ricky Sun, Risa J Lavizzo-mourey, Robert Glassman, Robert J. Hombach, Robert M Davis, Robert M Plenge, Robert Matthew Lutz, Ronald J Daniels, Sanat Chattopadhyay, Sarah A O'Dowd, Scott D Sandell, Shehnaaz Suliman, Srinivas Akkaraju, Stephen Mayo, Stephen W Webster, Steven Gillis, Surendralal Lanca Karsanbhai, Teresa Marie Bitetti, Theodore Alan Huizenga, Thomas H Glocer, Thomas Trimarchi, Timothy P Walbert, Todd Shegog, Vikas Sinha, Viviane Monges, Wan-Shan Chen, Willard H Dere, William D. Waddill, William J Chase, William R Jellison, Wim Souverijns, Xiao-Hui Chen, Yasmine Wasfi, Yoshiaki Fujimori, Yu-Hsin Lin, Zosia Piotrowska, MD) carry an employment edge and no prior approval that this search found. That is a searched and found nothing result across 280 people, not a survey of every executive in the sector, and it is not evidence that nobody else in biotech closes a loop like this.",
"evidence": [
"modig",
"knolle",
"icatibant",
"deucrictibant",
"deucrictibant_xr",
"phvs"
],
"src": "sec_phvs_ex99_1_pdf"
},
{
"id": "f_provenance",
"title": "6 of the dates here were re-read this week and 8 were carried, and the room says which",
"kind": "method",
"sev": "high",
"body": "Every claim in this record carries the address it came from and the words it was read from: 467 of 467, with no exceptions. The dates were the weak point, because they sat on the drug as properties rather than as claims, and properties carried no provenance at all. Re-sourcing them found that the most important number on each row was the least evidenced thing in the file. 6 were re-read against the sponsor's own release this week. 8 are carried forward from 17 September with the reason recorded per date: 0 sit behind walls that refuse automated access, proved as a refusal rather than assumed from a failed fetch, and the rest were read in full and the date is genuinely not on the page this record cites. None of the 8 was deleted. Method, so the check can be repeated: KXCO fetched each sponsor release on 2026-10-05, extracted the sentence carrying the date, and stored that sentence against the drug; where no such sentence could be obtained the date kept its 17 September provenance and the reason was recorded. A page that prints every date as though all were equally checked is the normal thing, and it is the thing this room refuses to be.",
"evidence": [
"lonvo_z",
"deucrictibant",
"bezuclastinib",
"tinlarebant",
"fayuvi"
],
"src": "ir_intellia_therapeutics_announces_fda_ac"
},
{
"id": "f_removed_date",
"title": "A date with no source came out of the record rather than being quietly corrected",
"kind": "method",
"sev": "medium",
"body": "Baxdrostat carried a target of 18 May 2026. Nothing in this record supports that value: the AstraZeneca release it cites carries no date at all, and the FDA approval history gives 15 May 2026 as the decision. The unsourced target was removed rather than corrected to the sourced one, because we never knew 18 May was the goal date and replacing it would have invented a second fact to cover the first. The same test then caught a worse case: 6 drugs held a target that was simply a copy of their approval date, which made them look like decisions that landed exactly on target. A difference between a number and a copy of itself is not a measurement. All 6 were cleared and one genuine measurement survives, Fayuvi at 2 days early.",
"evidence": [
"baxdrostat",
"azn",
"orforglipron",
"oveporexton",
"rusfertide",
"apitegromab"
],
"src": "drugs_baxfendy_html"
},
{
"id": "f_score_removed",
"title": "The record was evened, the model then passed, and that is why it was removed",
"kind": "self-correction",
"sev": "medium",
"body": "Both cohorts were searched again under one rule: phase 3, the drug named, the sponsor agreeing, no access or 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 the sign flipped, approved +3.38 against pending +3.08. The formula now passed. What it produced was a board topped by CagriSema on 22 registered phase 3 studies and Orforglipron on 18, because Novo Nordisk and Eli Lilly can afford to run them. The trials term counts studies, so a ranking built on it measures which sponsor is largest. The formula could be made to pass its test and passing was worse than failing, so it is withdrawn rather than repaired. Its components are kept and shown per drug because each is a counted fact. The board is ordered by regulatory standing and implied upside, from dated events rather than from a model. Correction, 30 September 2026: three of those CagriSema studies, RENEW 1, 2 and 4, test cagrilintide alone and were removed from the record. CagriSema now stands on 19 and the pending cohort on 3.25 trials per drug. The reasoning is unchanged.",
"evidence": [
"cagrisema",
"orforglipron",
"baxdrostat"
],
"src": "drugs_fayuvi_html"
},
{
"id": "f_withdrawn",
"title": "We published a failing model for a day, and the model was not the thing at fault",
"kind": "self-correction",
"sev": "medium",
"body": "This room carried an execution score, trials plus twice precedent plus twice closed loop minus twice adverse events, and published it failing its own backtest. The test compared the mean score of the approved cohort against the pending one and the approved names came out lower. We wrote that up as the formula being unable to credit back a refusal a company had overcome. That explanation was wrong. Traced on 23 September, the gap was 1.45 points and the adverse term accounted for 0.08 of it. The rest was us. ONE of the 8 approved drugs carried a registrational trial in this record and NINE of the 12 pending ones did, because the record was built as a screen of live filings, so the pending names were researched and the approved ones were entered as outcomes. A test between a researched cohort and an unresearched one measures which cohort was researched.",
"evidence": [
"fayuvi",
"apitegromab",
"pixclara",
"orforglipron",
"baxdrostat"
],
"src": "drugs_fayuvi_html"
}
]
}