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11 FDA decisions (PDUFA target action dates) fall in March 2027: 8 with a confirmed day. Next: Cabozantinib (EXEL) on Mar 3. Each row shows the drug, company, indication, status and how firm the date is.
| Date | Company | Drug | Indication | Event | Status | Date | Track |
|---|---|---|---|---|---|---|---|
| ~March | REGN | Garetosmab | Fibrodysplasia Ossificans Progressiva | PDUFA | Pending | AI-detected · source | |
| Mar 3 | EXEL | Cabozantinib | Solid Tumors | PDUFA | Pending | Confirmed · source | |
| ~March | XENE | Azetukalner | epilepsy | PDUFA | Pending | Estimated · source | |
| Mar 10 | NTLA | NTLA-2002 | hereditary angioedema (“HAE”) | PDUFA | Pending | Confirmed · source | |
| Mar 16 | AQST | Anaphylm (dibutepinephrine) sublingual film | Type I allergic reactions, including anaphylaxis | PDUFA | Pending | Confirmed · source | |
| Mar 22 | MRK | Clesrovimab | Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease through their second RSV season | PDUFA | Pending | Confirmed · source | |
| Mar 25 | UNCY | Oxylanthanum Carbonate | Chronic Kidney Disease Requiring Chronic Dialysis | PDUFA | Pending | Confirmed · source | |
| Mar 29 | ETON | LIBERVANT (diazepam buccal film) | Seizure clusters / acute repetitive seizures in patients with epilepsy (label expansion to ages 6 to 11) | PDUFA | Pending | Confirmed · source | |
| Mar 29 | AQST | Diazepam Buccal Film | Seizure clusters / acute repetitive seizures in patients with epilepsy, label expansion to ages 6 to 11 | PDUFA | Pending | Confirmed · source | |
| Mar 31 | ATRA | Tabelecleucel (Tab-cel®) | EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) | PDUFA | Pending | AI-detected · source | |
| ~March | TEVA | ecopipam | Pediatric Tourette Syndrome | PDUFA | Pending | AI-detected · source |
153
Total Catalysts
11
PDUFA Dates
138
Trial Results
94
Companies
Week 1Mar 1 - Mar 7(12 catalysts)
- Mar 2027~GSKBelantamab mafodotin (12 weeks) Phase 2 Est. Readout
- Mar 2027~NVOCagriSema (Cagrilintide B and Semaglutide I) Phase 3 Est. Readout
- Mar 2027~PFETucatinib Phase 2 Est. Readout
- Mar 2027~HNPHYHS-20137 Phase 2 Est. Readout
- Mar 2027~VRNAEnsifentrine Phase 2 Est. Readout
- Mar 2027~MRNAmRNA-1647 Phase 2 Est. Readout
- Mar 2027~HNPHYHS-20089 Phase 3 Est. Readout
- Mar 2027~AAPGolverembatinib Phase 2 Est. Readout
Week 2Mar 8 - Mar 14(11 catalysts)
- Q1 2027~QPFEPF-07275315 Phase 2 Est. Readout
- Mar 2027~AZNAZD7760 Phase 2 Est. Readout (PEAK)
- Q1 2027~QUCBJYbimekizumab Phase 3 Est. Readout
- Mar 2027~BMYNivolumab Phase 3 Est. Readout
- Mar 2027~TVTXSparsentan Phase 2 Est. Readout (EPPIK)
- Mar 2027~VRTXVX-264 Phase 2 Est. Readout
- Mar 2027~TSHATSHA-101 Phase 2 Est. Readout
- Mar 2027~RYTMSetmelanotide Phase 3 Est. Readout
- Mar 2027~OTSKFSibeprenlimab Phase 2 Est. Readout (EnVISage)
- Q1 2027~QZLABZL-1109 (VRDN-003) Phase 3 Est. Readout
Week 3Mar 15 - Mar 21(80 catalysts)
- Mar 2027~ARGXEfgartigimod IV Phase 3 Est. Readout (ADAPT Jr)
- Mar 2027~GILDSacituzumab Govitecan-hziy (SG) Phase 2 Est. Readout (EVOKE-02)
- Mar 2027~RHHBYTrastuzumab and Pertuzumab (FDC SC) and T-DM1 Phase 2 Est. Readout (PHERGAIN-2)
- Mar 2027~GSKDostarlimab Phase 2 Est. Readout (RADIAN)
- Mar 2027~ABBVUpadacitinib Phase 3 Est. Readout (SELECT-SLE)
- Mar 2027~NVSAsciminib Phase 2 Est. Readout (CMLXI)
- Mar 2027~PCVX31-valent pneumococcal conjugate vaccine Phase 3 Est. Readout
- Mar 2027~MRKLenvatinib Phase 2 Est. Readout
- Mar 2027~JHPCYSHR-A2102 or/and HRS-4642 Phase 2 Est. Readout
- Mar 2027~VNDAVCA-894A Phase 2 Est. Readout
- Mar 2027~MRKTILT-123 Phase 2 Est. Readout
- Mar 2027~NVSAlpelisib (BYL719) Phase 2 Est. Readout
- Mar 2027~JHPCYSHR0302 Tablets Phase 2 Est. Readout
- Mar 2027~BMEAicovamenib Phase 2 Est. Readout
- Mar 2027~GPCRACCG-2671 Phase 2 Est. Readout
- Mar 2027~ABBVLivmoniplimab Phase 2 Est. Readout
- Mar 2027~IBRXAnktiva Phase 2 Est. Readout
- Mar 2027~URGNUGN-104 Phase 3 Est. Readout
- Mar 2027~4151.Tziftomenib Phase 2 Est. Readout
- Mar 2027~AMGNRomosozumab Prefilled Syringe Phase 2 Est. Readout
- Mar 2027~EWTXSevasemten Dose 2 Phase 2 Est. Readout
- Mar 2027~COGTCGT4859 Phase 2 Est. Readout
- Mar 2027~STOKzorevunersen Phase 3 Est. Readout
- Mar 2027~LLYMacupatide Phase 2 Est. Readout
- Mar 2027~GMABEpcoritamab Phase 2 Est. Readout
- Mar 2027~ABBVCariprazine Phase 3 Est. Readout
- Mar 2027~SPTXSPT-300 Phase 2 Est. Readout
- Mar 2027~TAKC1 Esterase Inhibitor Injection Phase 2 Est. Readout
- Mar 2027~DNLIBIIB122 Phase 2 Est. Readout
- Mar 2027~RTSNRTN-001 Phase 2 Est. Readout
- Mar 2027~OCGNOCU400 Low Dose Phase 2 Est. Readout
- Mar 2027~IONSOlezarsen Phase 3 Est. Readout
- Mar 2027~AGIOAG-120 Phase 2 Est. Readout
- Mar 2027~JHPCYRezvilutamide Tablets Phase 3 Est. Readout
- Mar 2027~AMGNBlinatumomab Phase 2 Est. Readout
- Mar 2027~BMRNVosoritide Injection Phase 2 Est. Readout
- Mar 2027~GILDOral Lenacapavir Phase 2 Est. Readout
- Mar 2027~SOBI.STIntravenous immunoglobulin Phase 3 Est. Readout
- Mar 2027~SWTOYFludarabine and Dexamethasone Phase 2 Est. Readout
- Mar 2027~JHPCYRezvilutamide Phase 2 Est. Readout
- Mar 2027~ALLR2X-121 Phase 2 Est. Readout
- Mar 2027~DCPHInlexisertib Phase 2 Est. Readout
- Mar 2027~ONCTacabrutideg Phase 2 Est. Readout
- Mar 2027~TAKFEIBA Phase 3 Est. Readout (SAFE)
- Mar 2027~ALPMYEnfortumab Vedotin Phase 2 Est. Readout
- Mar 2027~MDGLResmetirom Phase 3 Est. Readout
- Mar 2027~SOBI.STEfanesoctocog alfa Phase 3 Est. Readout (LIBERTY)
- Mar 2027~MNKDTechnosphere Insulin Phase 2 Est. Readout
- Mar 2027~OCULIntravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24 Phase 3 Est. Readout (HELIOS-3)
- Mar 2027~MNKDTechnosphere Insulin Phase 2 Est. Readout (INHALE-1st)
- Mar 2027~SWTOYEmapalumab Phase 2 Est. Readout
- Mar 2027~RCUSZimberelimab Phase 2 Est. Readout (VELOCITY-HNSCC)
- Mar 2027~ABBVABBV-932 Phase 2 Est. Readout
- Mar 2027~ALGSALG-000184 Phase 2 Est. Readout (B-SUPREME)
- Mar 2027~ONCTacabrutideg Phase 2 Est. Readout (CaDAnCe-101)
- Mar 2027~VSTMDefactinib Phase 2 Est. Readout
- Mar 2027~CGENCOM701 Phase 2 Est. Readout (MAIA-ovarian)
- Mar 2027~FARN.LBexmarilimab Phase 2 Est. Readout (BEXMAB)
- Mar 2027~BIIBanti-TNF therapy Phase 3 Est. Readout (CRI-RA)
- Mar 2027~OCGNOCU400 Med Dose Phase 2 Est. Readout
- Mar 2027~EWTXSevasemten Dose 1 Phase 2 Est. Readout (FOX)
- Mar 2027~SOBI.STANAKINRA Phase 3 Est. Readout (ANACOMP)
- Mar 2027~IPN.PALanreotide Phase 2 Est. Readout (LAMPARA)
- Mar 2027~PEPGPGN-EDODM1 Phase 2 Est. Readout (FREEDOM2-DM1)
- Mar 2027~LLYSolbinsiran Phase 2 Est. Readout (SOLARIS-1)
- Mar 2027~NUVBNUV-1511 Phase 2 Est. Readout
- Mar 2027~JHPCYHRS-4642 Phase 2 Est. Readout
- Mar 2027~AZNOlaparib Phase 2 Est. Readout
- Mar 2027~MOLN4D-150 IVT Phase 2 Est. Readout
- Mar 2027~CLDXAnti-CD40 Agonist Monoclonal Antibody CDX-1140 Phase 2 Est. Readout
- Mar 2027~BGNEZanubrutinib Pill Phase 2 Est. Readout
- Mar 2027~NVSImatinib Phase 2 Est. Readout
- Mar 2027~BIIBbaricitinib treatment Phase 3 Est. Readout
- Mar 2027~TAKTAK-755 Phase 3 Est. Readout
- Mar 2027~ITCIITI-1284 Phase 2 Est. Readout
- Mar 2027~PFEtofacitinib Phase 3 Est. Readout
- Mar 2027~PCYCIbrutinib Phase 3 Est. Readout
- Mar 2027~LLYNiraparib Tosylate Monohydrate Phase 2 Est. Readout (NICHOL)
Week 4Mar 22 - Mar 28(17 catalysts)
- Mar 2027~REGNcemiplimab Phase 3 Est. Readout
- Mar 2027~MRKLenvatinib Phase 2 Est. Readout
- Mar 2027~DSKYFTrastuzumab deruxtecan Phase 2 Est. Readout (DPT02)
- Mar 2027~NVSEDI048 Phase 2 Est. Readout (CRYPTONITE)
- Q1 2027~QNVSCryptosporidium parvum oocysts (ABO809) Phase 2 Est. Readout
- Mar 2027~IVBXFIBI3002 Phase 2 Est. Readout
- Mar 2027~ARVNARV-471 Phase 2 Est. Readout
- Mar 2027~VRTXVX-993 Phase 2 Est. Readout
- Mar 2027~SNYFitusiran Phase 3 Est. Readout (ATLAS-NEO)
- Mar 2027~NVSIanalumab Phase 3 Est. Readout (SIRIUS-SLE 1)
- Mar 2027~IPN.PACorabotase Phase 2 Est. Readout (CATALPA)
- Mar 2027~HLUN-B.COEptinezumab Phase 3 Est. Readout (PROSPECT-2)
- Q1 2027~QIPSEYIPN10200 Phase 2 Est. Readout (CATALPA)
- Mar 2027~TAKZasocitinib Phase 2 Est. Readout
Week 5Mar 29 - Apr 4(33 catalysts)
- Mar 2027~UCBJYStaccato alprazolam Phase 3 Est. Readout
- Mar 2027~PBMPsilocybin therapy Phase 2 Est. Readout
- Mar 2027~GILDSacituzumab govitecan Phase 3 Est. Readout (SASCIA)
- Mar 2027~SGIOYS-488210/S-488211 Phase 2 Est. Readout (DURANCE)
- Mar 2027~INVAVI-0609 Phase 2 Est. Readout
- Mar 2027~HURAIFx-Hu2.0 Phase 3 Est. Readout
- Mar 2027~AAPGOlverembatinib Phase 3 Est. Readout
- Mar 31CGENData Readout — COM701
- Mar 2027~TNGXTNG456 Phase 2 Est. Readout
- Mar 2027~RHHBYEnglumafusp alfa Phase 2 Est. Readout
- Mar 2027~MRKTATE and pembrolizumab Phase 2 Est. Readout
- Mar 2027~MSLESAT-3247 Phase 2 Est. Readout (BASECAMP)
- Mar 2027~RHHBYAtezolizumab Phase 3 Est. Readout (Astefania)
- Q1 2027~QPFERitlecitinib Phase 3 Est. Readout (Tranquillo LTE)
- Mar 2027~CLDXHuman CMV pp65-LAMP mRNA-pulsed autologous DCs Phase 2 Est. Readout (DERIVe)
- Mar 2027~RHHBYSatralizumab Phase 3 Est. Readout (SAkuraSun)
- Mar 2027~NWRN.SWEvenamide Phase 3 Est. Readout (ENIGMA-TRS 2)
- Mar 2027~IVBXFfulzerasib Phase 2 Est. Readout (K-NADIR)
- Mar 2027~PFETalazoparib Phase 2 Est. Readout
- Mar 2027~HSCSEmpagliflozin Phase 2 Est. Readout (CRAVE)
- Mar 2027~MRKPosaconazole Phase 2 Est. Readout
- Mar 2027~ESALYE7389-LF Phase 2 Est. Readout
- Q1 2027~QBAYRYFinerenone Oral Tablet Phase 2 Est. Readout
- Mar 2027~ESALYLenvatinib Phase 2 Est. Readout
- Mar 2027~ONCBGB-B2033 Phase 2 Est. Readout
- Mar 2027~BGNEGlofitamab Phase 2 Est. Readout
- Mar 2027~CGONCretostimogene Grenadenorepvec Phase 2 Est. Readout
- Q1 2027~QAZNAZD4360 Phase 2 Est. Readout
- Mar 2027~NVSCTL019 Phase 3 Est. Readout
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PDUFA dates March 2027: questions
- How many FDA decisions (PDUFA dates) are in March 2027?
- 11 PDUFA dates fall in March 2027: 8 with a confirmed day. Updated November 6, 2026.
- What is the next FDA decision in March 2027?
- Cabozantinib from Exelixis, Inc. (EXEL), PDUFA target date Mar 3, for Solid Tumors.
- 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 March 2027
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for March 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.