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18 FDA decisions (PDUFA target action dates) fall in November 2026: 14 with a confirmed day, 1 already decided. Next: Sublingual film containing Dexmedetomidine (BTAI) on Nov 14. Each row shows the drug, company, indication, status and how firm the date is.
| Date | Company | Drug | Indication | Event | Status | Date | Track |
|---|---|---|---|---|---|---|---|
| Nov 10 | NRXP | Preservative-free Ketamine | — | PDUFA | Approved | Confirmed · source | |
| Nov 14 | BTAI | Sublingual film containing Dexmedetomidine | At-home acute treatment of agitation associated with bipolar disorders or schizophrenia | PDUFA | Pending | Confirmed · source | |
| Nov 14 | CYTK | Aficamten (CK-3773274) | Obstructive hypertrophic cardiomyopathy (label update based on MAPLE-HCM) | PDUFA | Pending | Confirmed · source | |
| Nov 14 | SMMT | Ivonescimab Injection | EGFR-mutated non-squamous NSCLC after prior EGFR TKI therapy | PDUFA | Pending | Confirmed · source | |
| ~November | REGN | Cemdisiran | Anti-AChR antibody-positive generalized myasthenia gravis | PDUFA | Pending | Estimated · source | |
| ~November | ALNY | cemdisiran | Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive | PDUFA | Pending | Estimated · source | |
| ~November | RHHBY | Obinutuzumab/Intravenous | Primary membranous nephropathy | PDUFA | Pending | Estimated · source | |
| Nov 22 | CAPR | Deramiocel (CAP-1002) | Duchenne muscular dystrophy (upper limb function) | PDUFA | Pending | Confirmed · source | |
| Nov 22 | SVRA | Molgramostim | Autoimmune pulmonary alveolar proteinosis | PDUFA | Pending | Confirmed · source | |
| Nov 25 | SNY | Venglustat | Type 3 Gaucher disease | PDUFA | Pending | Confirmed · source | |
| Nov 27 | BBIO | BBP-418 | Limb-girdle muscular dystrophy type 2I/R9 | PDUFA | Pending | Confirmed · source | |
| Nov 27 | GSK | Neladalkib (NVL-655) | TKI pre-treated advanced ALK-positive NSCLC | PDUFA | Pending | Confirmed · source | |
| ~November | BBOT | BBP-418 | — | PDUFA | Pending | AI-detected · source | |
| Nov 27 | RPRX | neladalkib | non-small cell lung cancer (ALK-positive) | PDUFA | Pending | Confirmed · source | |
| Nov 28 | PYPD | D-PLEX | Prevention of surgical site infections in abdominal colorectal surgery | PDUFA | Pending | Confirmed · source | |
| Nov 30 | ZLAB | povetacicept | immunoglobulin A nephropathy (IgAN) | PDUFA | Pending | Confirmed · source | |
| Nov 30 | RHHBY | Giredestrant | Adjuvant ER-positive, HER2-negative stage I-III breast cancer | PDUFA | Pending | Confirmed · source | |
| Nov 30 | VRTX | Povetacicept | IgA nephropathy | PDUFA | Pending | Confirmed · source |
170
Total Catalysts
18
PDUFA Dates
94
Trial Results
129
Companies
Week 1Oct 26 - Nov 1(9 catalysts)
- Nov 1RDYOther - semaglutide
- Nov 2026~REGNDupilumab Phase 2 Est. Readout
- Nov 2026~PHVSIcatibant Phase 3 Est. Readout
- Nov 2026~CRBPCRB-601 monoclonal antibody Phase 2 Est. Readout
- Nov 2026~BMYKarXT Phase 3 Est. Readout (BALSAM-1)
- Nov 2026~GSKBelantamab mafodotin Phase 2 Est. Readout
- Nov 2026~SRRKApitegromab Phase 3 Est. Readout (ONYX)
- Nov 2026~ESALYLenvatinib Phase 2 Est. Readout
- Nov 2026~GILDSacituzumab Govitecan-Hziy plus bevacizumab Phase 2 Est. Readout
Week 2Nov 2 - Nov 8(50 catalysts)
- Nov 2026~ENLVAllocetra Phase 2 Est. Readout
- Nov 2KVAUFKVAUF M&A / Acquisition
- Nov 2026~REGNFixed Dose Combination (FDC) cemiplimab+fianlimab Phase 2 Est. Readout
- Nov 2TOVXTOVX M&A / Acquisition
- Nov 2SUPNSUPN M&A / Acquisition
- Nov 2026~TLSAForalumab Nasal Phase 2 Est. Readout
- Nov 2INDVINDV M&A / Acquisition
- Nov 2KPTIAcquisition — Ayrmid Ltd. ($55M)
- Nov 2BIAFBIAF — Stock Offering (424B5)
- Nov 2026~RHHBYRisdiplam Phase 3 Est. Readout (MANATEE)
- Nov 3MDWDMDWD — Stock Offering (424B5)
- Nov 3CRDLStock Offering
- Nov 3LONN.SWAcquisition — Merck KGaA
- Nov 3RMTIAcquisition — Vantive Limited ($400M)
- Nov 2026~TLSAForalumab Nasal Phase 2 Est. Readout
- Nov 2026~REGNCemiplimab Phase 3 Est. Readout
- Nov 2026~NVSLOU064 (blinded) Phase 3 Est. Readout
- Nov 4QNRXQNRX — Stock Offering (424B5)
- Nov 4DSGNDSGN — Stock Offering (424B5)
- Nov 4ANVSANVS — Stock Offering (424B5)
- Nov 4ARQTARQT — Stock Offering (424B5)
- Nov 4WVEConference Presentation
- Nov 4GNTAOther
- Nov 4BIVIBIVI — Stock Offering (424B5)
- Nov 5AVTXAVTX — Stock Offering (424B5)
- Nov 5DTILStock Offering — $79.4M (10.24M shares at $7.75, calculated; excludes any underwriter option)
- Nov 5NBIXConference Presentation
- Nov 5IMUXConference Presentation
- Nov 5ISPCISPC M&A / Acquisition
- Nov 5AZNAcquisition — Rhythm Pharmaceuticals ($10B)
- Nov 2026~IQVBedaquiline, pretomanid and TBD09 Phase 2 Est. Readout
- Nov 5IVAConference
- Nov 2026~PCVX31-valent pneumococcal conjugate vaccine Phase 3 Est. Readout
- Nov 2026~AZNAZD9750 Phase 2 Est. Readout
- Nov 5INOINO — Stock Offering (424B5)
- Nov 5DRTSOther - Alpha DaRT
- Nov 5OBIOOBIO — Stock Offering (424B5)
- Nov 5FATEFATE — Stock Offering (424B5)
- Nov 2026~INCYparsaclisib + itacitinib Phase 2 Est. Readout
- Nov 5ANIPAcquisition — Egetis Therapeutics AB ($300M)
- Nov 5VYGRVYGR M&A / Acquisition
- Nov 5TECXTECX M&A / Acquisition
- Nov 2026~TLSAForalumab Nasal Phase 2 Est. Readout
- Nov 6EVAXConference — EVX-01
- Nov 6JSPROther
- Nov 6RGENStock Offering
Week 3Nov 9 - Nov 15(58 catalysts)
- Nov 9MDCXConference Presentation - CD228V
- Nov 9MNPRConference — ALXN1840
- Nov 9HELPConference Presentation - HLP003
- Nov 9PFEConference
- Nov 10QNTMOther
- Nov 2026~PGENPRGN-2009 plus Pembrolizumab Phase 2 Est. Readout
- Nov 11RGNXConference Presentation
- Nov 2026~EXELCabozantinib Phase 2 Est. Readout (CANOPY)
- Nov 12OKYOConference Presentation - urcosimod
- Nov 2026~PFEPF-07275315 Phase 2 Est. Readout
- Nov 13IBOAcquisition
- Nov 2026~REGNREGN7075 Phase 2 Est. Readout (COMBINE-EGFR-1)
- Nov 2026~RHHBYInavolisib Phase 3 Est. Readout (INAVO121)
- Nov 13NTHIConference Presentation - NEO100
- Nov 2026~WXIBGM0504 Administered Phase 3 Est. Readout
- Nov 2026~WXIBGM0504 Administered Phase 3 Est. Readout
- Nov 2026~VIRTobevibart Phase 2 Est. Readout
- Nov 2026~PFEPertuzumab Phase 2 Est. Readout (BRIDGET)
- Nov 2026~TYRATYRA-300 Phase 2 Est. Readout (SURF301)
- Nov 2026~CRDFOnvansertib Phase 2 Est. Readout
- Nov 2026~BYSIPlinabulin Phase 2 Est. Readout
- Nov 2026~SDZ.SWCYB704 Phase 3 Est. Readout
- Nov 2026~BGNETislelizumab (BGB-A317) Phase 2 Est. Readout
- Nov 2026~ALKSALKS 2680 Phase 2 Est. Readout (Vibrance-3)
- Nov 2026~SVAexperimental vaccine Phase 3 Est. Readout
- Nov 2026~LLYLY3938577 Phase 2 Est. Readout
- Nov 2026~BNTXRO7198457 intravenous (IV) Phase 2 Est. Readout
- Nov 2026~TNXPCyclobenzaprine HCl Phase 2 Est. Readout (OASIS)
- Nov 2026~SKBBYSKB264 Phase 3 Est. Readout
- Nov 2026~PCRXEnekinragene Inzadenovec (PCRX-201) Phase 2 Est. Readout
- Nov 2026~IGCIGC-AD1-Active Phase 2 Est. Readout
- Nov 2026~TXMDABT-101 Phase 2 Est. Readout
- Nov 2026~REGNREGN2810 Phase 2 Est. Readout
- Nov 2026~ABBVVenetoclax Phase 2 Est. Readout (ReVenG)
- Nov 2026~GSKDostarlimab Phase 2 Est. Readout
- Nov 2026~AZNDurvalumab Phase 2 Est. Readout
- Nov 2026~SNYIsatuximab Phase 2 Est. Readout (UltraFrailMM)
- Nov 2026~ARGXEmpasiprubart IV Phase 2 Est. Readout (empacific)
- Nov 2026~ONCSonrotoclax Phase 2 Est. Readout
- Nov 2026~CGONCretostimogene Grenadenorepvec Phase 3 Est. Readout
- Nov 2026~ABBVUpadacitinib Phase 3 Est. Readout (Switch-Up)
- Nov 2026~IMUXIMU-838 tablets Phase 3 Est. Readout (ENSURE-1)
- Nov 2026~KPRXKIO-104 Phase 2 Est. Readout (KLARITY-1)
- Nov 2026~KYKOYMogamulizumab Phase 2 Est. Readout
- Nov 2026~NAMSobicetrapib + obicetrapib/evolocumab Phase 2 Est. Readout (VINCENT)
- Nov 2026~NAMSObicetrapib Phase 3 Est. Readout (PREVAIL)
- Nov 2026~CAMX.STCAM2029 Phase 3 Est. Readout (SORENTO)
- Nov 2026~ICLRBXQ-350 Phase 2 Est. Readout (ASIST)
- Nov 2026~JHPCYSHR-A1811 combined with Pyrotinib Phase 2 Est. Readout
- Nov 2026~ATOS(Z)-endoxifen Phase 2 Est. Readout (EVANGELINE)
Week 4Nov 16 - Nov 22(13 catalysts)
- Nov 2026~PTCTConference Presentation
- Nov 2026~OTSKFDelamanid (DLM) Phase 3 Est. Readout (PHOENIx MDR-TB)
- Nov 2026~BIOA-B.STConference Presentation - Leqembi
- Nov 17JAZZConference Presentation
- Nov 2026~AZNAZD0901 Phase 2 Est. Readout
- Nov 2026~DSGNALECENSA - alectinib hydrochloride capsule Phase 3 Est. Readout (Drugs-SNPs)
- Nov 19ICCMOther
- Nov 19MDXHOther
- Nov 2026~RHHBYRO7269162 Phase 2 Est. Readout
- Nov 2026~SKYENimacimab injection Phase 2 Est. Readout (CBeyond)
- Nov 2026~INCYpovorcitinib Phase 2 Est. Readout
Week 5Nov 23 - Nov 29(15 catalysts)
- Nov 2026~GSKDostarlimab Phase 2 Est. Readout
- Nov 2026~GSKdTpa Phase 3 Est. Readout
- Nov 2026~KRTXKarXT Phase 3 Est. Readout
- Nov 2026~MKKGYAvelumab Phase 3 Est. Readout
- Nov 24CLGNOther
- Nov 2026~TECXTX000045- Dose A Phase 2 Est. Readout
- Nov 2026~AZNAZD0754 Phase 2 Est. Readout (APOLLO)
- Nov 2026~SNYMeasles, combinations with mumps and rubella, live attenuated Phase 3 Est. Readout
- Q4 2026~QPFERimegepant Phase 3 Est. Readout
Week 6Nov 30 - Dec 6(25 catalysts)
- Nov 2026~NTHIPerillyl alcohol Phase 2 Est. Readout
- Nov 2026~AMGNAnvumetostat Phase 2 Est. Readout
- Nov 2026~IMCRIMC-R117C Phase 2 Est. Readout
- Nov 2026~TXMDGS1191-0445 injection Phase 3 Est. Readout
- Nov 2026~AZNTremelimumab Phase 2 Est. Readout
- Nov 2026~TXMDRNK08954 Phase 2 Est. Readout
- Nov 2026~RHHBYAtezolizumab Phase 3 Est. Readout
- Nov 2026~BIOAOral BGE-102 Phase 2 Est. Readout (QUELL-CV)
- Q4 2026~QIRLADexamethasone sodium phosphate Phase 3 Est. Readout
- Q4 2026~QSNYrilzabrutinib Phase 3 Est. Readout
- Nov 2026~PHARLeniolisib Phase 3 Est. Readout
- Nov 2026~IVBXFIBI363 Phase 2 Est. Readout
- Nov 2026~BAVA.COMVA-BN (Quail) Phase 2 Est. Readout
- Nov 2026~TAKTAK-360 Phase 2 Est. Readout
- Nov 2026~SKBBYA166 Phase 3 Est. Readout
- Nov 2026~MRNAmRNA-3745 Phase 2 Est. Readout
- Nov 2026~VTRSMR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) Phase 2 Est. Readout
- Nov 2026~ARVNARV-806 Phase 2 Est. Readout
- Nov 2026~AURAAU-011 Phase 2 Est. Readout
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PDUFA dates November 2026: questions
- How many FDA decisions (PDUFA dates) are in November 2026?
- 18 PDUFA dates fall in November 2026: 14 with a confirmed day, 1 already decided. Updated November 6, 2026.
- What is the next FDA decision in November 2026?
- Sublingual film containing Dexmedetomidine from BioXcel Therapeutics, Inc. (BTAI), PDUFA target date Nov 14, for At-home acute treatment of agitation associated with bipolar disorders or schizophrenia.
- 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 November 2026
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for November 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.