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Biotech catalyst calendar — PDUFA dates, readouts and advisory committees

Every upcoming FDA decision, advisory committee and trial readout we maintain, with the filing it came from, the date at the precision the company stated it, and the cash position behind it.

Event table: 2026-09-21
Filing signals: 2026-09-21
Market links: none matched
Events: 25 in this window

Each block carries its own time. This page was assembled 2026-09-21, which is not evidence that anything under it was refreshed then.

Event type

Date confidence

Public float

Runway vs event

Significance

Catalyst events, Next 60 days (2026-09-21 to 2026-11-20), plus events resolved in the last 7 days · Event table maintained 2026-09-21
Company	Event	Date	Float	Stake	Runway	Financing	Holders	Insider net	Research	Yours	Calls
ARGXARGENX SEPhase 3	Phase 3 toplineEmpasiprubartMultifocal Motor Neuropathy (MMN)identity unresolved	2026-09Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.Window open	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

RGNXREGENXBIO Inc.Phase 3	Phase 3 toplineRGX-202Duchenne Muscular Dystrophyidentity unresolved	2026-09Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.Window open	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

VNDAVanda Pharmaceuticals Inc.Phase 3	Phase 3 toplineTasimelteonSleep Wake Disordersidentity unresolved	2026-09Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.Window open	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

MLTXMoonLake ImmunotherapeuticsPhase 3	Phase 3 toplineSonelokimabHidradenitis Suppurativaidentity unresolved	2026-09-28Exact day · EstimatedIn 7d Countdown: In 7d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

OCGNOcugen, Inc.Phase 3	Phase 3 toplineOCU410STStargardt Diseaseidentity unresolved	2026-09-28Exact day · EstimatedIn 7d Countdown: In 7d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

GLAXFGSK plcPhase 3	Phase 3 toplineDepemokimabEosinophilic Granulomatosis With Polyangiitisidentity unresolved	2026-09-29Exact day · EstimatedIn 8d Countdown: In 8d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

AZNASTRAZENECA PLCPhase 3	Phase 3 toplineDato-DXdMetastatic Non-small Cell Lung Canceridentity unresolved	2026-09-30Exact day · EstimatedIn 9d Countdown: In 9d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

AZNASTRAZENECA PLCPhase 3	Phase 3 toplineDurvalumabNon-Small Cell Lung Canceridentity unresolved	2026-09-30Exact day · EstimatedIn 9d Countdown: In 9d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

AZNASTRAZENECA PLCPhase 3	Phase 3 toplineDurvalumabHepatocellular Carcinomaidentity unresolved	2026-09-30Exact day · EstimatedIn 9d Countdown: In 9d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

GLAXFGSK plcPhase 3	Phase 3 toplineRSVPreF3 OA vaccineRespiratory Syncytial Virus Infectionsidentity unresolved	2026-09-30Exact day · EstimatedIn 9d Countdown: In 9d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

GLAXFGSK plcPhase 3	Phase 3 toplineLinerixibatCholestasisidentity unresolved	2026-09-30Exact day · EstimatedIn 9d Countdown: In 9d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

ARGXARGENX SEPhase 3	Phase 3 toplineefgartigimod PH20 SCPrimary Immune Thrombocytopeniaidentity unresolved	2026-10-01Exact day · EstimatedIn 10d Countdown: In 10d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

XENEXenon Pharmaceuticals Inc.Phase 3	Phase 3 toplineXEN1101Focal Onset Seizuresidentity unresolved	2026-10Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

SNYNFSanofiPhase 3	Phase 3 toplineItepekimab (SAR440340)Chronic Rhinosinusitis With Nasal Polypsidentity unresolved	2026-10-14Exact day · EstimatedIn 23d Countdown: In 23d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

ANNXAnnexon, Inc.Phase 3	Phase 3 toplineVonaprumentGeographic Atrophyidentity unresolved	2026-10-31Exact day · EstimatedIn 40d Countdown: In 40d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

AZNASTRAZENECA PLCPhase 3	Phase 3 toplineCapivasertibBreast Canceridentity unresolved	2026-10-31Exact day · EstimatedIn 40d Countdown: In 40d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

OLMAOlema Pharmaceuticals, Inc.Phase 3	Phase 3 toplinePalazestrantBreast Canceridentity unresolved	2026-10-31Exact day · EstimatedIn 40d Countdown: In 40d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

CGONCG Oncology, Inc.Phase 3	Phase 3 toplineCretostimogene GrenadenorepvecNon Muscle Invasive Bladder Canceridentity unresolved	2026-11Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

DBVTFDBV Technologies S.A.Phase 3	Phase 3 toplineDBV712 250 mcgAllergyidentity unresolved	2026-11Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

IMUXIMMUNIC, INC.Phase 3	Phase 3 toplineIMU-838 tabletsMultiple Sclerosis, Relapsing-Remittingidentity unresolved	2026-11Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

IMUXIMMUNIC, INC.Phase 3	Phase 3 toplineIMU-838 tabletsMultiple Sclerosisidentity unresolved	2026-11Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

SVASINOVAC BIOTECH LTDPhase 3	Phase 3 toplineexperimental vaccineEpidemic Meningitisidentity unresolved	2026-11Month · Estimatedno countdown Countdown: not available. Only an exact date carries a countdown.	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

AZNASTRAZENECA PLCPhase 3	Phase 3 toplineAnifrolumabCutaneous Lupus Erythematosusidentity unresolved	2026-11-02Exact day · EstimatedIn 42d Countdown: In 42d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

SNYNFSanofiPhase 3	Phase 3 toplineItepekimab (SAR440340)Chronic Rhinosinusitis With Nasal Polypsidentity unresolved	2026-11-06Exact day · EstimatedIn 46d Countdown: In 46d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

AZNASTRAZENECA PLCPhase 3	Phase 3 toplineTrastuzumab deruxtecanBreast Cancer; HER2-positive; Metastaticidentity unresolved	2026-11-11Exact day · EstimatedIn 51d Countdown: In 51d	Float: not available. No public float has been reported at a usable date.	Stake: not available. Research for this company needs an account. The sample companies are fully interactive without one.	Runway: not available. Cash or burn is missing, so no runway verdict is made.	Financing: not available. No financing filing in the period covered.	Holders: not available. No specialist 13F quarter has been read for this issuer.	Insider net: not available. No open-market insider transaction was filed in the window.	Research probability: not available. This event is not joined to a researched indication.	anonymous non sampleYour probability: Research for this company needs an account. The sample companies are fully interactive without one.	Calls: not available. Nobody has published a call on this event.

Dates are what the company, FDA or the trial registry stated, at the precision they stated them. Nothing here is a prediction of an outcome, and no price, implied move or market probability is collected or shown. The research probability is this model’s own estimate of ultimate approval, carrying the date the research was done.