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17 FDA decisions (PDUFA target action dates) fall in February 2027: 11 with a confirmed day. Next: Infigratinib (BBIO) on Feb 4. Each row shows the drug, company, indication, status and how firm the date is.
| Date | Company | Drug | Indication | Event | Status | Date | Track |
|---|---|---|---|---|---|---|---|
| Feb 1 | AGIO | Mitapivat | Sickle cell disease | PDUFA | Delayed | Confirmed · source | |
| Feb 4 | BBIO | Infigratinib | children with achondroplasia | PDUFA | Pending | Confirmed · source | |
| Feb 7 | VSTM | AVMAPKI FAKZYNJA CO-PACK (Blister Pack) | — | PDUFA | Pending | Confirmed · source | |
| Feb 9 | RHHBY | Mosunetuzumab | Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) | PDUFA | Pending | Confirmed · source | |
| Feb 12 | BLTE | Tinlarebant | Stargardt Disease Type 1 | PDUFA | Pending | Confirmed · source | |
| ~February | DCPH | Tirabrutinib | relapsed or refractory PCNSL | PDUFA | Pending | Estimated · source | |
| ~February | REGN | Odronextamab | relapsed or refractory diffuse large B-cell lymphoma (DLBCL) | PDUFA | Pending | Estimated · source | |
| ~February | ARGX | Efgartigimod | pediatric generalized myasthenia gravis (gMG) | PDUFA | Pending | Estimated · source | |
| ~February | GSK | Dostarlimab | Previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer | PDUFA | Pending | Estimated · source | |
| ~February | RGNX | RGX-121 | Hunter syndrome | PDUFA | Pending | AI-detected · source | |
| Feb 23 | ARQT | Roflumilast | Mild to moderate atopic dermatitis in infants aged 3 to 24 months | PDUFA | Pending | Confirmed · source | |
| ~February | LRMR | CTI-1601 | Friedreich's Ataxia | PDUFA | Pending | Estimated · source | |
| Feb 27 | CGEM | CLN-081 | patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy | PDUFA | Pending | Confirmed · source | |
| Feb 28 | LGND | Qtorin rapamycin | microcystic lymphatic malformations | PDUFA | Pending | Confirmed · source | |
| Feb 28 | PVLA | — | — | PDUFA | Pending | AI-detected · source | |
| Feb 28 | BMRN | Vosoritide Injection | Achondroplasia in children (full approval) | PDUFA | Pending | Confirmed · source | |
| Feb 28 | APMD | AD109 (Oxnimbi) | Obstructive sleep apnea (OSA) | PDUFA | Pending | Confirmed · source |
113
Total Catalysts
17
PDUFA Dates
93
Trial Results
66
Companies
Week 1Feb 1 - Feb 7(17 catalysts)
- Feb 2027~EXELCabozantinib Phase 2 Est. Readout
- Feb 2027~GILDSacituzumab Govitecan (SG) Phase 2 Est. Readout
- Feb 1PPCBPhase 1 — PRP
- Feb 2027~AMGNAutologous Stem Cell Transplant (ASCT) Phase 2 Est. Readout (ADVANCE)
- Feb 2027~AZNGC012F Injection Phase 2 Est. Readout
- Feb 2027~EPZMTazemetostat Phase 2 Est. Readout
- Feb 2027~ABBVTelisotuzumab Vedotin Phase 2 Est. Readout
- Feb 2027~NVSLEE011 Phase 2 Est. Readout
- Feb 2027~NVSLXH254 Phase 2 Est. Readout
- Feb 2027~VRTXVX-670 Phase 2 Est. Readout (Galileo)
- Feb 2027~RHHBYRanibizumab Phase 3 Est. Readout
- Feb 2027~NVSSoC (Coartem) Phase 2 Est. Readout
- Feb 2027~TAKZasocitinib (Dose A) Phase 2 Est. Readout
- Feb 2027~BMYNivolumab Phase 2 Est. Readout
Week 2Feb 8 - Feb 14(15 catalysts)
- Feb 2027~REGNREGN9933 Phase 2 Est. Readout (ROXI-ATLAS)
- Feb 2027~SNYBrivekimig Phase 2 Est. Readout (BRIGHTEN)
- Feb 2027~DSKYFTrastuzumab deruxtecan Phase 2 Est. Readout
- Feb 2027~TAKTeduglutide Phase 3 Est. Readout
- Q1 2027~QRHHBYRanibizumab Phase 2 Est. Readout
- Feb 2027~AZNAZD4144 Phase 2 Est. Readout (SERENIA)
- Feb 2027~SNYRilzabrutinib dose 1 Phase 2 Est. Readout
- Feb 2027~NVSInclisiran Phase 3 Est. Readout
- Feb 2027~MRKPembrolizumab Phase 2 Est. Readout
- Feb 2027~EPZMTazemetostat Phase 3 Est. Readout (SYMPHONY-1)
- Feb 2027~ESALYE2086 Phase 2 Est. Readout
Week 3Feb 15 - Feb 21(52 catalysts)
- Feb 2027~ENLVAllocetra Phase 2 Est. Readout
- Feb 2027~ABBVMEDI0618 Phase 2 Est. Readout (AURORA)
- Feb 2027~MRNAmRNA-1403 Phase 3 Est. Readout (Nova 301)
- Feb 2027~INCYRuxolitinib Phase 2 Est. Readout
- Feb 2027~RHHBYAtezolizumab Injection Phase 2 Est. Readout
- Feb 2027~ABBVLutikizumab Phase 2 Est. Readout
- Feb 2027~ABCLABCL635 Phase 2 Est. Readout
- Feb 2027~AZNTremelimumab Phase 2 Est. Readout
- Feb 2027~REC.MIPasireotide Phase 2 Est. Readout
- Feb 2027~AZNAcalabrutinib Phase 2 Est. Readout
- Feb 2027~ALM.MCLAD328 Phase 2 Est. Readout
- Feb 2027~AZNDurvalumab Phase 2 Est. Readout
- Feb 2027~RHHBYVenetoclax Phase 3 Est. Readout
- Feb 2027~EXELCabozantinib Phase 2 Est. Readout
- Feb 2027~TXMDYL201 for Injection Phase 2 Est. Readout
- Feb 2027~CADLaglatimagene besadenovec + valacyclovir Phase 2 Est. Readout
- Feb 2027~ABBVMirvetuximab Soravtansine Phase 2 Est. Readout
- Feb 2027~JAZZCannabidivarin Phase 2 Est. Readout
- Feb 2027~ABBVRavagalimab Phase 2 Est. Readout
- Feb 2027~GNLXPlatinum chemotherapy: carboplatin or cisplatin Phase 2 Est. Readout
- Feb 2027~ARWRARO-ALK7 Phase 2 Est. Readout
- Feb 2027~BAVA.COMVA-BN-WEV Phase 2 Est. Readout
- Feb 2027~NBIXValbenazine Oral Capsule Phase 2 Est. Readout
- Feb 2027~NBIXNBI-1065890 Phase 2 Est. Readout
- Feb 2027~RHHBYVenetoclax Phase 2 Est. Readout
- Feb 2027~BAYRYFOLFOX chemotherapy with oxaliplatin Phase 2 Est. Readout
- Feb 2027~JHPCYFH-006 for Injection Phase 2 Est. Readout
- Feb 2027~IPN.PAOdevixibat Phase 3 Est. Readout (ASSERT-EXT)
- Feb 2027~IPSEYOdevixibat Phase 3 Est. Readout (ASSERT-EXT)
- Feb 2027~ALCApraclonidine Ophthalmic Solution, Unit Dose Preservative Free Phase 3 Est. Readout
- Feb 2027~ONCZanubrutinib Phase 2 Est. Readout
- Feb 2027~INCYItacitinib Phase 2 Est. Readout
- Feb 2027~LLYBrenipatide Phase 2 Est. Readout (RENEW-Smk-1)
- Feb 2027~KODKSI-101 Phase 3 Est. Readout (PINNACLE)
- Feb 2027~KRYSKB707 Phase 2 Est. Readout (KYANITE-1)
- Feb 2027~SXTPTafenoquine Phase 2 Est. Readout (TQ-BA-2024-3)
- Feb 2027~GNLXOlvimulogene nanivacirepvec Phase 2 Est. Readout (VIRO-25)
- Feb 2027~IQVER004 Phase 2 Est. Readout (EDELIFE)
- Feb 2027~BMYRepotrectinib Phase 3 Est. Readout
- Feb 2027~TAKTAK-279 Phase 2 Est. Readout
- Feb 2027~SNYItepekimab (SAR440340) Phase 3 Est. Readout (CEREN-3)
- Feb 2027~MRKTulisokibart Phase 2 Est. Readout
- Feb 2027~AZNZibotentan/Dapagliflozin Phase 3 Est. Readout
- Feb 2027~JHPCYPD-1 blocking antibody Phase 3 Est. Readout
- Feb 2027~REGNREGN7508 Phase 3 Est. Readout (ROXI-APEX)
- Feb 2027~RHHBYTocilizumab (Actemra®) Phase 2 Est. Readout (IDENTIFY)
- Feb 2027~SKBBYSKB518 Phase 2 Est. Readout
- Feb 2027~MRKR-CHOP Protocol Phase 2 Est. Readout
Week 4Feb 22 - Feb 28(29 catalysts)
- Feb 2027~AZNOsimertinib Phase 3 Est. Readout
- Feb 2027~AZNAnifrolumab Phase 3 Est. Readout (IRIS)
- Feb 2027~OTSKFBedaquiline (B) Phase 2 Est. Readout (PARADIGM4TB)
- Feb 2027~MRTXAdagrasib Phase 2 Est. Readout
- Feb 2027~NVSPertuzumab Phase 3 Est. Readout
- Feb 2027~RHHBYCevostamab Phase 2 Est. Readout (CAMMA 2)
- Feb 2027~NVSLEE011 Phase 2 Est. Readout
- Feb 2027~NVSAlpelisib Phase 2 Est. Readout
- Feb 2027~ARDXTenapanor Phase 3 Est. Readout
- Feb 2027~IONSPhase 1
- Feb 28CGEMPhase 3 — zipalertinib
- Q1 2027~QREGNREGN5715 Phase 3 Est. Readout
- Feb 2027~NTHINEO212 Oral Capsule Phase 2 Est. Readout
- Feb 28TRAXPhase 3 — zipalertinib
- Feb 2027~IVBXFSintilimab Phase 2 Est. Readout
- Feb 2027~IVBXFAflibercept Ophthalmic Phase 3 Est. Readout
- Feb 2027~IVBXFIBI302 Phase 3 Est. Readout
- Feb 2027~ABBVVenetoclax Phase 2 Est. Readout
- Feb 2027~HNSA.STImlifidase Phase 2 Est. Readout (DINKY)
- Feb 2027~LLYPirtobrutinib Phase 2 Est. Readout
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PDUFA dates February 2027: questions
- How many FDA decisions (PDUFA dates) are in February 2027?
- 17 PDUFA dates fall in February 2027: 11 with a confirmed day. Updated November 6, 2026.
- What is the next FDA decision in February 2027?
- Infigratinib from BridgeBio Pharma, Inc. (BBIO), PDUFA target date Feb 4, for children with achondroplasia.
- 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 February 2027
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for February 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.