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11 FDA decisions (PDUFA target action dates) fall in January 2027: 11 with a confirmed day, 4 already decided. Next: NTLA (NTLA) on Jan 2. Each row shows the drug, company, indication, status and how firm the date is.
| Date | Company | Drug | Indication | Event | Status | Date | Track |
|---|---|---|---|---|---|---|---|
| Jan 2 | NTLA | — | — | PDUFA | Pending | AI-detected · source | |
| Jan 3 | ARGX | Efgartigimod | generalized myasthenia gravis | PDUFA | Pending | Confirmed · source | |
| Jan 4 | NUVB | Taletrectinib | Non Small Cell Lung Cancer | PDUFA | Approved | Confirmed · source | |
| Jan 6 | IBRX | Nogapendekin alfa inbakicept | BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without CIS | PDUFA | Approved | Confirmed · source | |
| Jan 10 | RHHBY | satralizumab | Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) | PDUFA | Approved | Confirmed · source | |
| Jan 18 | HRMY | HBS-102 | narcolepsy | PDUFA | Pending | AI-detected · source | |
| Jan 18 | ETON | ET-105 | adult refractory gastroesophageal reflux disease (rGERD) | PDUFA | Pending | AI-detected · source | |
| Jan 21 | DYN | Zeleciment Rostudirsen (DYNE-251) | DMD who are amenable to exon 51 skipping | PDUFA | Pending | Confirmed · source | |
| Jan 28 | INSM | Arikayce™ | Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen | PDUFA | Pending | Confirmed · source | |
| Jan 29 | PRAX | PRAX-944 | Essential tremor | PDUFA | Pending | Confirmed · source | |
| Jan 30 | PHAR | Leniolisib | activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 years and older weighing 13 kg to 27 kg | PDUFA | Approved | Confirmed · source |
127
Total Catalysts
11
PDUFA Dates
102
Trial Results
82
Companies
Week 1Dec 28 - Jan 3(31 catalysts)
- Jan 2027~CTMXData Readout - Varsetatug masetecan (Varseta-M, CX-2051)
- Jan 2027~LLYOther
- Jan 2027~GILDPartnership - Gamgertamig
- Jan 1ABBVData Readout
- Jan 2027~TEVADTIC Phase 2 Est. Readout
- Jan 1PPBTPhase 1 — IM1240
- Jan 2027~IOVAE7 TCR-T cells Phase 2 Est. Readout
- Jan 2027~REPLRP2 Injection Phase 2 Est. Readout (INTERCEPT)
- Jan 2027~ABBVLiposomal daunorubicin and cytarabine Phase 2 Est. Readout
- Jan 1CLDXPhase 3 — barzolvolimab
- Jan 1JBIOPhase 1 — JADE201
- Jan 2027~SIGATecovirimat Phase 2 Est. Readout
- Jan 2027~PFEEnfortumab Vedotin Phase 2 Est. Readout
- Jan 2027~INCYRuxolitinib Phase 2 Est. Readout
- Jan 1TNXPPartnership — TONMYA®
- Jan 2027~RGNXPhase 3
- Jan 2027~RNXTPhase 3
- Jan 1OKURTrial Start
- Jan 1CCCCData Readout — Cemsidomide
- Jan 2027~NVSdabrafenib/trametinib Phase 2 Est. Readout
- Jan 2027~AZNCediranib Phase 2 Est. Readout
- Jan 2027~NBPPhase 2 Results - givastomig
- Jan 2027~PFETrial Start
- Jan 2027~REGNOdronextamab Phase 2 Est. Readout
Week 2Jan 4 - Jan 10(12 catalysts)
- Jan 2027~AZNAZD0780 Phase 3 Est. Readout (AZURE-HeFH)
- Jan 2027~PHO.OLCysview Phase 3 Est. Readout
- Jan 2027~MLTXSonelokimab Phase 3 Est. Readout (IZAR-2)
- Jan 2027~AMGNAMG 732 Phase 2 Est. Readout
- Jan 2027~INCYINCA034176 Phase 2 Est. Readout
- Jan 2027~ARGXefgartigimod administration Phase 3 Est. Readout
- Jan 2027~SNYPCV21 Phase 3 Est. Readout
- Jan 2027~OCULOTX-TKI Phase 3 Est. Readout
Week 3Jan 11 - Jan 17(39 catalysts)
- Jan 2027~AZNAZD0780 Phase 3 Est. Readout (AZURE-LDL)
- Jan 2027~DSKYFDato-DXd Phase 3 Est. Readout (TROPION-Lung15)
- Q1 2027~QGSKAdjuvanted RSVPreF3 vaccine Phase 2 Est. Readout
- Jan 2027~GILDSacituzumab Govitecan Phase 3 Est. Readout
- Jan 2027~MRKPembrolizumab Phase 3 Est. Readout
- Jan 2027~NVOUBT251 Phase 2 Est. Readout
- Jan 2027~REC.MIosilodrostat Phase 2 Est. Readout
- Jan 2027~IDYAIDE196 Phase 3 Est. Readout
- Jan 2027~ALCApraclonidine Ophthalmic Solution, Unit Dose Preservative Free Phase 3 Est. Readout
- Jan 2027~AMGNPegfilgrastim Phase 2 Est. Readout
- Jan 2027~LABTAntimicrobial agent Phase 2 Est. Readout
- Jan 2027~LRMRCTI-1601 Phase 2 Est. Readout
- Jan 2027~ACADPimavanserin Phase 2 Est. Readout
- Jan 2027~RAREsetrusumab Phase 3 Est. Readout
- Jan 2027~TAKFOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Phase 2 Est. Readout
- Jan 2027~CALCCM4620 Phase 2 Est. Readout
- Jan 2027~MRK9vHPV Vaccine Phase 3 Est. Readout
- Jan 2027~ESALYLenvatinib + Letrozole Phase 2 Est. Readout
- Jan 2027~BCYCBT8009 Phase 2 Est. Readout
- Jan 2027~BMYNivolumab Phase 2 Est. Readout
- Jan 2027~TLX68Ga-PSMA-11 Phase 3 Est. Readout (BiPASS)
- Jan 2027~AZNDurvalumab Phase 2 Est. Readout
- Jan 2027~GILDTilpisertib Fosmecarbil Phase 2 Est. Readout
- Jan 2027~SVAexperimental vaccine Phase 3 Est. Readout
- Jan 2027~ELDNAT-1501 Phase 2 Est. Readout
- Jan 2027~LXRXSotagliflozin Phase 3 Est. Readout (SONATA-HCM)
- Jan 2027~MIRMVolixibat Phase 2 Est. Readout (VANTAGE)
- Jan 2027~MKKGYBintrafusp alfa Phase 2 Est. Readout (TRUST)
- Jan 2027~EWTXSevasemten Dose 2 Phase 2 Est. Readout
- Jan 2027~MRKPembrolizumab Phase 2 Est. Readout
- Jan 2027~INCYTafasitamab Phase 2 Est. Readout
- Jan 2027~PRAXvormatrogine Phase 3 Est. Readout (POWER2)
- Jan 2027~CLVSRucaparib Phase 2 Est. Readout
- Jan 2027~ABBVLivmoniplimab Phase 3 Est. Readout (LIVIGNO-2)
- Jan 2027~XENEAzetukalner Phase 3 Est. Readout (X-NOVA-OLE)
- Jan 2027~SNYefanesoctocog alfa (BIVV001) Phase 3 Est. Readout (XTEND-ed)
- Jan 2027~BIIBTofersen Phase 2 Est. Readout
- Jan 2027~RXRXREC-4881 Phase 2 Est. Readout
- Jan 2027~CRBPCRB-701 Phase 2 Est. Readout
Week 4Jan 18 - Jan 24(11 catalysts)
- Jan 2027~SNYInvestigational hMPV/RSV vaccine Phase 2 Est. Readout
- Jan 2027~TAKMaribavir Phase 3 Est. Readout
- Jan 2027~PFERSVpreF Phase 3 Est. Readout (RENOIR)
- Jan 2027~AZNSavolitinib Phase 2 Est. Readout (SOUND)
- Jan 2027~RHHBYAlectinib Phase 3 Est. Readout (HORIZON 1)
- Jan 2027~SNYSAR445877 Phase 2 Est. Readout
- Jan 2027~AMGNMaridebart cafraglutide Phase 3 Est. Readout
- Jan 2027~TGTXUblituximab Phase 3 Est. Readout (ENHANCE)
Week 5Jan 25 - Jan 31(34 catalysts)
- Jan 2027~NVSJDQ443 Phase 2 Est. Readout (KontRASt-01)
- Jan 2027~VRTXSuzetrigine Phase 3 Est. Readout
- Jan 2027~NVOInsulin icodec Phase 3 Est. Readout
- Jan 2027~GSKFF/UMEC/VI Phase 3 Est. Readout
- Q1 2027~QNVSAlpelisib Phase 3 Est. Readout (EPIK-B5)
- Jan 2027~MRNAmRNA-1018-H5 Phase 3 Est. Readout
- Jan 2027~SNYrF1V-1018 Phase 2 Est. Readout
- Jan 2027~IDYAIDE196 Phase 2 Est. Readout
- Jan 2027~AZNAZD9550 Phase 2 Est. Readout (CONTEMPO)
- Jan 2027~AZNCasdatifan Phase 3 Est. Readout (eVOLVE-RCC02)
- Jan 2027~NVSiptacopan Phase 3 Est. Readout (APPEAR-C3G)
- Jan 2027~PFEdisitamab vedotin Phase 3 Est. Readout
- Jan 2027~NVSAlpelisib Phase 2 Est. Readout
- Jan 2027~NVOZiltivekimab Phase 3 Est. Readout (ARTEMIS)
- Jan 2027~4519.TAfimkibart Phase 3 Est. Readout (Ametrine-1)
- Jan 2027~IQVIxovex-1 Phase 2 Est. Readout (IXACT)
- Jan 2027~LPTXDKN-01 Phase 2 Est. Readout
- Jan 2027~APLMAPL-101 Phase 2 Est. Readout
- Jan 2027~SCLP.LSCIB1 or iSCIB1+ DNA vaccine Phase 2 Est. Readout
- Jan 2027~PFEAvelumab Phase 2 Est. Readout (InCITe)
- Jan 31CANFPhase 3
- Jan 2027~QNRXQRX003 Phase 3 Est. Readout
- Jan 2027~EXELCabozantinib Phase 2 Est. Readout
- Q1 2027~QMRKFluorouracil (5-FU) Phase 3 Est. Readout
- Jan 2027~DSKYFDS-5141b Phase 2 Est. Readout
- Jan 2027~MRKPembrolizumab Phase 3 Est. Readout
- Q1 2027~QCELZCELZ-201 Administration Phase 2 Est. Readout
- Jan 2027~ZNTLAzenosertib Phase 2 Est. Readout
- Jan 2027~RHHBYObinutuzumab Phase 2 Est. Readout
- Jan 2027~MRKNirogacestat Phase 2 Est. Readout
- Jan 2027~INCYRetifanlimab Phase 2 Est. Readout (TRICK-MCC)
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PDUFA dates January 2027: questions
- How many FDA decisions (PDUFA dates) are in January 2027?
- 11 PDUFA dates fall in January 2027: 11 with a confirmed day, 4 already decided. Updated November 6, 2026.
- What is the next FDA decision in January 2027?
- FDA PDUFA Date (priority review) from Intellia Therapeutics, Inc. (NTLA), PDUFA target date Jan 2.
- 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 January 2027
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for January 2027. 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.