What is a PDUFA date?

The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

September 2026

PDUFA Dates October 2026: 13 FDA Decisions

Updated November 6, 2026

November 2026

These dates are public. The filterable calendar, alerts, exports and AI research are in the app — free account: the next 7 days and 3 companies you track. Plans →

13 FDA decisions (PDUFA target action dates) fall in October 2026: 12 with a confirmed day, 13 already decided. Each row shows the drug, company, indication, status and how firm the date is.

FDA decisions in October 2026
Date	Company	Drug	Indication	Event	Status	Date
Oct 9	AMGN	—	—	PDUFA	Approved	Confirmed
~October	TEVA	—	—	PDUFA	Approved	AI-detected · source
Oct 15	UCBJY	—	—	PDUFA	Approved	Confirmed
Oct 17	VTRS	MR-141 (phentolamine ophthalmic solution 0.75%)	Presbyopia	PDUFA	Approved	Confirmed · source
Oct 17	IRD	OPX-102	Achromatopsia	PDUFA	Approved	AI-detected · source
Oct 22	FYB.DE	—	—	PDUFA	Approved	Confirmed
Oct 22	AMGN	—	—	PDUFA	Approved	Confirmed
Oct 23	ABBV	—	—	PDUFA	Approved	Confirmed
Oct 24	PHAR	Leniolisib	Activated PI3K delta syndrome (APDS) in pediatric patients aged 4 to 11 years	PDUFA	Approved	AI-detected · source
Oct 26	IONS	bepirovirsen	chronic hepatitis B (CHB)	PDUFA	Approved	Confirmed · source
Oct 26	GSK	Bepirovirsen	Chronic hepatitis B in adults	PDUFA	Approved	Confirmed · source
Oct 26	PFE	—	—	PDUFA	Approved	Confirmed
Oct 30	INO	INO-3107	Recurrent respiratory papillomatosis in adults	PDUFA	Approved	Confirmed · source

156

Total Catalysts

PDUFA Dates

Trial Results

111

Companies

Week 1Oct 5 - Oct 11(11 catalysts)

AMGN$219.9BPDUFA

Past

FDA Approval: REPATHA

Oct 9Confirmed

✅ApprovedSource

TEVA$46.0BPDUFA

Oct '26

FDA PDUFA Date olanzapine extended-release injectable suspension (standard review)

Oct 2026~AI-detected

✓PositiveSource

Oct 2026~REGNDupilumab Phase 3 Est. ReadoutPhase 3
Oct 8SYREStock Offering — $350 millionOffering
Oct 2026~ARGXEfgartigimod IV Phase 3 Est. ReadoutPhase 3
Oct 2026~RHHBYTobemstomig Phase 2 Est. ReadoutPhase 2
Oct 8SXTCStock Offering — $12 MillionOffering
Oct 9QUCYQUCY — Stock Offering (424B5)Offering
Oct 9BIAFBIAF — Stock Offering (424B5)Offering
Oct 9HEPAHepion M&A / AcquisitionM&A
Oct 2026~INCYRuxolitinib Cream Phase 3 Est. ReadoutPhase 3

Week 2Oct 12 - Oct 18(47 catalysts)

UCBJY$46.1BPDUFA

Past

FDA Approval: ZILBRYSQ

Oct 15Confirmed

✅ApprovedSource

CRIS$5MRegulatory

Past

Curis, Inc. Announces Pricing of $8.5 Million Private Placement Priced At-the-Market Under Nasdaq Rules with Existing Healthcare Focused Institutional Investors

Oct 16Confirmed

📊Data ReleasedSource

VTRS$19.7BNDA Filing

Past

NDA Filing - MR-141

Oct 17AI-detected

00%

Source

VTRS$19.7BPDUFA

Past

FDA PDUFA Date MR-141 (phentolamine ophthalmic solution 0.75%)

MR-141 (phentolamine ophthalmic solution 0.75%)NDA

Presbyopia

Oct 17Confirmed

✓PositiveSource

IRD$398MPDUFA

Past

FDA PDUFA Date OPX-102 (standard)

OPX-102NDA

Achromatopsia

Oct 17AI-detected

✓PositiveSEC

Oct 2026~AZNDapagliflozin propanediol (FORXIGA™/FARXIGA™1) Phase 3 Est. ReadoutPhase 3
Oct 2026~BMYNivolumab Phase 2 Est. ReadoutPhase 2
Oct 12FLNAConferenceConference
Oct 2026~INCYtopical ruxolitinib Phase 2 Est. ReadoutPhase 2
Oct 2026~REGNCemdisiran Phase 3 Est. Readout (ACCESS-1)Phase 3
Oct 2026~GSKCobolimab Phase 2 Est. ReadoutPhase 2
Oct 13RHHBYAcquisition ($1B)M&A
Oct 2026~VRXAVY7523 Phase 2 Est. ReadoutPhase 2
Oct 13TCRTAlaunos M&A / AcquisitionM&A
Oct 13RDHLRDHL — Stock Offering (424B5)Offering
Oct 14VSTMStock Offering — $250MOffering
Oct 14FVNNRII M&A / AcquisitionM&A
Oct 14IARTStock Offering — $450 MillionOffering
Oct 2026~GSKMomelotinib Phase 2 Est. ReadoutPhase 2
Oct 2026~IMGNIMGN853 Phase 2 Est. ReadoutPhase 2
Oct 15RXRXRXRX — Stock Offering (424B5)Offering
Oct 2026~MIRMMaralixibat Phase 3 Est. ReadoutPhase 3
Oct 15FLSCII M&A / AcquisitionM&A
Oct 2026~RAPPRAP-219 Phase 2 Est. ReadoutPhase 2
Oct 2026~TXMDBHV-7000 Phase 3 Est. ReadoutPhase 3
Oct 2026~NVSAAA617 Phase 2 Est. Readout (PSMAndARPI)Phase 2
Oct 2026~CLDXbarzolvolimab Phase 3 Est. Readout (EMBARQ-CSU2)Phase 3
Oct 2026~IMCRBrenetafusp Phase 2 Est. ReadoutPhase 2
Oct 2026~REGNVV1 Phase 2 Est. ReadoutPhase 2
Oct 2026~IMVTIMVT-1402 Phase 2 Est. ReadoutPhase 2
Oct 2026~VNDAiloperidone Phase 2 Est. ReadoutPhase 2
Oct 2026~CLDXBarzolvolimab Phase 2 Est. ReadoutPhase 2
Oct 2026~MPLTML-004 (IR)/(ER) tablet Phase 2 Est. ReadoutPhase 2
Oct 2026~CORTDazucorilant Phase 2 Est. ReadoutPhase 2
Oct 2026~GILDSacituzumab Govitecan-hziy Phase 2 Est. ReadoutPhase 2
Oct 2026~ABOSsabirnetug Phase 2 Est. ReadoutPhase 2
Oct 2026~NVSInclisiran Phase 3 Est. ReadoutPhase 3
Oct 2026~NVSribociclib Phase 2 Est. ReadoutPhase 2
Oct 2026~BMYMilvexian Phase 3 Est. ReadoutPhase 3
Oct 2026~PHIL.MIOnfekafusp alfa Phase 2 Est. ReadoutPhase 2
Oct 2026~AZNOsimertinib Phase 2 Est. ReadoutPhase 2
Oct 2026~TXMDYL201 for Injection Phase 2 Est. ReadoutPhase 2
Oct 15ISCOConferenceConference
Oct 16VTRSViatris Receives U.S. FDA Approval for RYZUMVI® for the Treatment of PresbyopiaData Readout
Oct 16ALECStock Offering — $75MOffering
Oct 16AIBTAIBOTICS, M&A / AcquisitionM&A
Oct 2026~BGNEBGB-45035 Phase 2 Est. ReadoutPhase 2

Week 3Oct 19 - Oct 25(40 catalysts)

UNCY$134MRegulatory

Past

INVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Unicycive Therapeutics, Inc. to Contact Law Firm

Oct 20Confirmed

📊Data ReleasedSource

FYB.DE$376MPDUFA

Past

FDA Approval: AHZANTIVE

Oct 22Confirmed

✅ApprovedSource

AMGN$219.9BPDUFA

Past

FDA Approval: PAVBLU

Oct 22Confirmed

✅ApprovedSource

ABBV$468.2BPDUFA

Past

FDA Approval: SKYRIZI

Oct 23Confirmed

✅ApprovedSource

PHAR$766MPDUFA

Past

FDA PDUFA Date Joenja (leniolisib)

LeniolisibPhase 3

Activated PI3K delta syndrome (APDS) in pediatric patients aged 4 to 11 years

Oct 24AI-detected

✅ApprovedSEC

Oct 19VVOSVivos M&A / AcquisitionM&A
Oct 2026~BMYDeucravacitinib Phase 3 Est. Readout (POETYK SLE-1)Phase 3
Oct 19SLNAcquisition — Merck KGaA ($1.3B)M&A
Oct 2026~INCYPovorcitinib Phase 3 Est. ReadoutPhase 3
Oct 2026~MRKTrifluridine-Tipiracil Phase 3 Est. Readout (TroFuse-015)Phase 3
Oct 2026~MRKRescue medications Phase 3 Est. Readout (TroFuse-015)Phase 3
Oct 19MKKGYAcquisition — Silence Therapeutics ($1.3B)M&A
Oct 19DWTXStock Offering — $5 millionOffering
Oct 20LLYConferenceConference
Oct 2026~OTSKFSEP-363856 Phase 3 Est. ReadoutPhase 3
Oct 20TKNOTKNO — Stock Offering (424B5)Offering
Oct 2026~BIIBLitifilimab Phase 3 Est. Readout (AMETHYST)Phase 3
Oct 20SRZNStock Offering — $95.1 millionOffering
Oct 20INDPINDP Corporate UpdateOther
Oct 20IRONIRON — Stock Offering (424B5)Offering
Oct 21DMAARDMAAR M&A / AcquisitionM&A
Oct 21SWTOYConference — Aspaveli/EmpaveliConference
Oct 21RCUSRCUS — Stock Offering (424B5)Offering
Oct 21NNVCNNVC — Stock Offering (424B5)Offering
Oct 21ALCAcquisition — Neurotech Pharmaceuticals ($550M)M&A
Oct 2026~RHHBYGlofitamab Phase 2 Est. ReadoutPhase 2
Oct 2026~AMGNDazodalibep Phase 3 Est. ReadoutPhase 3
Oct 2026~RHHBYOcrelizumab Phase 3 Est. ReadoutPhase 3
Oct 23ZNTLConference — azenosertibConference
Oct 23LNAILNAI Corporate UpdateOther
Oct 23CMPXConference — tovecimigConference
Oct 23BKHABKHA Corporate UpdateOther
Oct 23SKBBYConferenceConference
Oct 23CYDYData Readout — leronlimabData Readout
Oct 23IMRNIMRN — Stock Offering (424B5)Offering
Oct 23HCMConferenceConference
Oct 23BOLTBOLT M&A / AcquisitionM&A
Oct 23IDYAConference — DarovasertibConference
Oct 23MRKConference — Sacituzumab TirumotecanConference
Oct 24AMGNConference PresentationConference

Week 4Oct 26 - Nov 1(58 catalysts)

CTOR$94MRegulatory

Past

Citius Oncology Reports Continued Institutional Demand and 120% Growth in Shipments of LYMPHIR® Units to U.S. Wholesalers During the Fiscal Fourth Quarter of 2026

Oct 26Estimated

00%

Source

IONS$7.2BPDUFA

Past

FDA PDUFA Date bepirovirsen (priority)

bepirovirsenNDA

chronic hepatitis B (CHB)

Oct 26Confirmed

✅ApprovedSEC

GSK$100.5BPDUFA

Past

FDA PDUFA Date Bepirovirsen

BepirovirsenPhase 2

Chronic hepatitis B in adults

Oct 26Confirmed

✅ApprovedSource

PFE$160.0BPDUFA

Past

FDA Approval: TALZENNA

Oct 26Confirmed

✅ApprovedSource

PRGO$2.0BRegulatory

Past

Perrigo Announces Quarterly Dividend

Oct 29Confirmed

📊Data ReleasedSource

INO$129MPDUFA

Past

FDA PDUFA Date INO-3107

INO-3107Phase 2

Recurrent respiratory papillomatosis in adults

Oct 30Confirmed

✓PositiveSource

PTCT$5.3BRegulatory

Past

PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Oct 30Confirmed

📊Data ReleasedSource

INMB$56MRegulatory

Past

Regulatory — Ebstrocel

Oct 31AI-detected

00%

Source

RHHBY$351.3BRegulatory

Past

Regulatory

Oct 31AI-detected

00%

Source

Oct 2026~TEVAFp/ABS Phase 3 Est. ReadoutPhase 3
Oct 2026~GALDYNemolizumab Phase 3 Est. ReadoutPhase 3
Oct 2026~NVSInclisiran Sodium Phase 3 Est. Readout (V-PLAQUE)Phase 3
Oct 26SNTISNTI M&A / AcquisitionM&A
Oct 27NANONANO M&A / AcquisitionM&A
Oct 2026~AZNTremelimumab Phase 3 Est. Readout (TRITON)Phase 3
Oct 27ACTUStock Offering — $11MOffering
Oct 27RAPPRAPP — Stock Offering (424B5)Offering
Oct 27ACRSACRS — Stock Offering (424B5)Offering
Oct 2026~AZNLenvatinib Phase 2 Est. ReadoutPhase 2
Oct 2026~IPN.PAOdevixibat Phase 3 Est. Readout (BOLD-EXT)Phase 3
Oct 28INMBStock Offering — $4.50 millionOffering
Oct 2026~MRKBelzutifan Phase 3 Est. ReadoutPhase 3
Oct 2026~BGNEZanubrutinib Phase 2 Est. ReadoutPhase 2
Oct 2026~RHHBYAfimkibart Phase 3 Est. Readout (Ametrine-2)Phase 3
Oct 2026~REC.MIPasireotide Diaspartate Phase 2 Est. Readout (PASIPHY)Phase 2
Oct 29NRSNNeuroSense to Present Integrated Clinical and Biomarker Evidence Shaping PrimeC's Phase 3 Development at NEALS 2026Data Readout
Oct 2026~NVSianalumab Phase 3 Est. ReadoutPhase 3
Oct 30VTRSAcquisition — Pacira BioSciences, Inc.M&A
Oct 30ANVSANVS Corporate UpdateOther
Oct 2026~SNYvenglustat (GZ402671) Phase 2 Est. ReadoutPhase 2
Oct 2026~VRTXVX-121/TEZ/D-IVA Phase 3 Est. ReadoutPhase 3
Oct 30VORVOR — Stock Offering (424B5)Offering
Oct 2026~MRKGAd-209-FSP low dose Phase 2 Est. ReadoutPhase 2
Oct 30ALLRALLR — Stock Offering (424B5)Offering
Oct 30APVOAPVO — Stock Offering (424B5)Offering
Oct 2026~MRTXAdagrasib Phase 2 Est. ReadoutPhase 2
Oct 30PTHSAcquisition — Castle Creek Biosciences, Inc. ($300M)M&A
Oct 2026~IVBXFIBI3003 Phase 2 Est. ReadoutPhase 2
Oct 2026~ALPMYzolbetuximab Phase 2 Est. ReadoutPhase 2
Oct 2026~GSKBelantamab Mafodotin-Blmf Phase 2 Est. ReadoutPhase 2
Oct 2026~4151.TKHK4951 Phase 2 Est. ReadoutPhase 2
Oct 2026~AZNALXN2220 Phase 2 Est. ReadoutPhase 2
Oct 2026~MAAT.PAPooled allogeneic fecal microbiotherapy Phase 2 Est. ReadoutPhase 2
Oct 2026~JHPCYSHR6390 Phase 3 Est. ReadoutPhase 3
Oct 2026~AMGNanvumetostat Phase 2 Est. ReadoutPhase 2
Oct 31DWTXPhase 2 — Halneuron®Phase 2
Oct 2026~MRKPembrolizumab Phase 2 Est. ReadoutPhase 2
Oct 2026~RHHBYAtezolizumab Phase 2 Est. Readout (PANDA)Phase 2
Oct 2026~TGTXUblituximab Phase 3 Est. ReadoutPhase 3
Oct 2026~SRPTEteplirsen Phase 3 Est. Readout (MIS51ON)Phase 3
Oct 31VKTXPhase 3 Results - VK2735Phase 3
Oct 2026~RYTMSetmelanotide Phase 2 Est. ReadoutPhase 2
Oct 2026~ORNBV.HEODM-208 Phase 2 Est. Readout (CYPIDES)Phase 2
Oct 2026~OLMAPalazestrant Phase 3 Est. Readout (OPERA-01)Phase 3
Oct 2026~RCUSZimberelimab Phase 2 Est. ReadoutPhase 2
Oct 2026~SYRESPY002-072 Phase 2 Est. Readout (SKYWAY-RD)Phase 2
Oct 2026~AZNCapivasertib Phase 3 Est. ReadoutPhase 3
Oct 2026~ZEALglepaglutide Phase 3 Est. ReadoutPhase 3

September 2026 Full Calendar November 2026

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PDUFA dates October 2026: questions

How many FDA decisions (PDUFA dates) are in October 2026?: 13 PDUFA dates fall in October 2026: 12 with a confirmed day, 13 already decided. Updated November 6, 2026.
What is a PDUFA date?: The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

About PDUFA Dates in October 2026

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for October 2026. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).

Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.

Learn more about PDUFA dates or view the full biotech catalyst calendar.