CatalystAlert

Search CatalystAlert

Search for companies, drugs, and catalysts

Search CatalystAlert

Search for companies, drugs, and catalysts

March 2027 Catalysts

FDA Decisions & PDUFA Dates

113
Total Catalysts
2
PDUFA Dates
110
Trial Results
79
Companies

Week 1Mar 1 - Mar 7(9 catalysts)

XENEPDUFA
Mar '27

FDA PDUFA Date azetukalner (standard review)

AzetukalnerPhase 3

Major Depressive Disorder

Mar 2027~
00%
Source
  • Mar 2027~NONOFCagriSema (Cagrilintide B and Semaglutide I) Phase 3 Est. Readout
  • Mar 2027~VRNAEnsifentrine Phase 2 Est. Readout
  • Mar 2027~DAWNTovorafenib Phase 2 Est. Readout
  • Mar 2027~SGENTucatinib Phase 2 Est. Readout
  • Q1 2027~QPFERitlecitinib Phase 2 Est. Readout
  • Mar 2027~MRNAmRNA-1647 Phase 2 Est. Readout
  • Mar 2027~AAPGolverembatinib Phase 2 Est. Readout
  • Mar 2027~HNSPFHS-20089 Phase 3 Est. Readout

Week 2Mar 8 - Mar 14(10 catalysts)

  • Q1 2027~QPFEPF-07275315 Phase 2 Est. Readout
  • Q1 2027~QUCBJYbimekizumab Phase 3 Est. Readout
  • Q1 2027~QREGNFixed Dose Combination (FDC) cemiplimab+fianlimab Phase 2 Est. Readout
  • Mar 2027~BMYNivolumab Phase 3 Est. Readout
  • Mar 2027~BMYIpilimumab Phase 3 Est. Readout
  • Q1 2027~QVRTXVX-264 Phase 2 Est. Readout
  • Mar 2027~TVTXSparsentan Phase 2 Est. Readout
  • Q1 2027~QRYTMSetmelanotide Phase 3 Est. Readout
  • Mar 2027~OTSKFSibeprenlimab Phase 2 Est. Readout
  • Q1 2027~QZLABZL-1109 (VRDN-003) Phase 3 Est. Readout

Week 3Mar 15 - Mar 21(57 catalysts)

  • Mar 2027~URGNUGN-104 Phase 3 Est. Readout
  • Mar 2027~BEIGFTacabrutideg Phase 2 Est. Readout
  • Mar 2027~JNGHFSHR-A2102 or/and HRS-4642 Phase 2 Est. Readout
  • Mar 2027~AZNCFOlaparib Phase 2 Est. Readout
  • Mar 2027~JNGHFRezvilutamide Phase 2 Est. Readout
  • Mar 2027~JNGHFHRS-4642 Phase 2 Est. Readout
  • Mar 2027~DCPHInlexisertib Phase 2 Est. Readout
  • Mar 2027~MRKPembrolizumab Phase 2 Est. Readout
  • Mar 2027~SWTOYFludarabine and Dexamethasone Phase 2 Est. Readout
  • Mar 2027~COGTCGT4859 Phase 2 Est. Readout
  • Mar 2027~BGNEZanubrutinib Pill Phase 2 Est. Readout
  • Mar 2027~STOKzorevunersen Phase 3 Est. Readout
  • Mar 2027~BAYRYbemdaneprocel Phase 3 Est. Readout
  • Mar 2027~MNKDTechnosphere Insulin Phase 2 Est. Readout
  • Mar 2027~GILDZimberelimab Phase 3 Est. Readout
  • Mar 2027~BMRNVosoritide Injection Phase 2 Est. Readout
  • Mar 2027~PCVX31-valent pneumococcal conjugate vaccine Phase 3 Est. Readout
  • Mar 2027~MOLN4D-150 IVT Phase 2 Est. Readout
  • Mar 2027~4151.Tziftomenib Phase 2 Est. Readout
  • Mar 2027~SPTXSPT-300 Phase 2 Est. Readout
  • Mar 2027~EWTXSevasemten Dose 2 Phase 2 Est. Readout
  • Mar 2027~AMGNBlinatumomab Phase 2 Est. Readout
  • Mar 2027~DNLIBIIB122 225 mg Phase 2 Est. Readout
  • Mar 2027~IONSOlezarsen Phase 3 Est. Readout
  • Mar 2027~CGENCOM701 Phase 2 Est. Readout
  • Mar 2027~SOBI.STIntravenous immunoglobulin Phase 3 Est. Readout
  • Mar 2027~OCGNOCU400 Low Dose Phase 2 Est. Readout
  • Mar 2027~IPN.PALanreotide Phase 2 Est. Readout
  • Mar 2027~PEPGPGN-EDODM1 Phase 2 Est. Readout
  • Mar 2027~CLDXAnti-CD40 Agonist Monoclonal Antibody CDX-1140 Phase 2 Est. Readout
  • Mar 2027~VSTMAvutometinib (VS-6766) Phase 2 Est. Readout
  • Mar 2027~LLYMacupatide Phase 2 Est. Readout
  • Mar 2027~TKPHFFEIBA Phase 3 Est. Readout
  • Mar 2027~GMABEpcoritamab Phase 2 Est. Readout
  • Mar 2027~MRKTILT-123 Phase 2 Est. Readout
  • Mar 2027~NUVBNUV-1511 Phase 2 Est. Readout
  • Mar 2027~FARN.LBexmarilimab Phase 2 Est. Readout
  • Mar 2027~BIIBbaricitinib treatment Phase 3 Est. Readout
  • Mar 2027~GILDOral Lenacapavir Phase 2 Est. Readout
  • Mar 2027~NVSImatinib Phase 2 Est. Readout
  • Mar 2027~VTRSTransdermal system containing progestin Phase 3 Est. Readout
  • Mar 2027~ALGSALG-000184 Phase 2 Est. Readout
  • Mar 2027~ALLR2X-121 Phase 2 Est. Readout
  • Mar 2027~OCULSingle intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 Phase 3 Est. Readout
  • Mar 2027~JHPCYSHR0302 Tablets Phase 2 Est. Readout
  • Mar 2027~ARGXEfgartigimod IV Phase 3 Est. Readout
  • Mar 2027~NVSEFAlpelisib (BYL719) Phase 2 Est. Readout
  • Mar 2027~BEIGFBGB-16673 Phase 3 Est. Readout
  • Mar 2027~VSTMDefactinib Phase 2 Est. Readout
  • Mar 2027~FOLDMiglustat Phase 3 Est. Readout
  • Mar 2027~ABBVCariprazine Phase 3 Est. Readout
  • Mar 2027~JNGHFRezvilutamide Tablets Phase 3 Est. Readout
  • Mar 2027~DCPHRipretinib Phase 2 Est. Readout
  • Mar 2027~TAKTAK-755 Phase 3 Est. Readout
  • Mar 2027~ITCIITI-1284 10 mg Phase 2 Est. Readout
  • Mar 2027~PCYCIbrutinib Phase 3 Est. Readout
  • Q1 2027~QUCBJYbimekizumab Phase 3 Est. Readout

Week 4Mar 22 - Mar 28(7 catalysts)

  • Mar 2027~REGNcemiplimab Phase 3 Est. Readout
  • Q1 2027~QMRKLenvatinib Phase 2 Est. Readout
  • Mar 2027~IVBXFIBI3002 Phase 2 Est. Readout
  • Q1 2027~QNVSEFCryptosporidium parvum oocysts (ABO809) Phase 2 Est. Readout
  • Q1 2027~QPFEabemaciclib Phase 3 Est. Readout
  • Q1 2027~QSNYFitusiran Phase 3 Est. Readout
  • Mar 2027~IPN.PACorabotase Phase 2 Est. Readout

Week 5Mar 29 - Apr 4(30 catalysts)

TEVAPDUFA
Mar '27

FDA PDUFA Date ecopipam (priority review)

ecopipamNDA

Pediatric Tourette Syndrome

Mar 2027~
00%
Source
  • Q1 2027~QSGIOYS-488210/S-488211 Phase 2 Est. Readout
  • Q1 2027~QNVSEFCTL019 Phase 3 Est. Readout
  • Q1 2027~QCGONCretostimogene Grenadenorepvec Phase 3 Est. Readout
  • Mar 2027~ESALYE7386 Phase 2 Est. Readout
  • Mar 2027~NWRN.SWEvenamide 15 mg bid Phase 3 Est. Readout
  • Mar 2027~MRKTATE and pembrolizumab Phase 2 Est. Readout
  • Mar 2027~ESALYE7389-LF Phase 2 Est. Readout
  • Mar 2027~AAPGOlverembatinib Phase 3 Est. Readout
  • Q1 2027~QTNGXTNG456 Phase 2 Est. Readout
  • Q1 2027~QBAYRYFinerenone Oral Tablet Phase 2 Est. Readout
  • Mar 2027~ESALYDoxorubicin Phase 2 Est. Readout
  • Mar 2027~ESALYLenvatinib Phase 2 Est. Readout
  • Q1 2027~QPFERitlecitinib 100 mg Phase 3 Est. Readout
  • Mar 2027~RHHBYTrastuzumab Phase 3 Est. Readout
  • Mar 2027~BEIGFBGB-B2033 Phase 2 Est. Readout
  • Q1 2027~QIPIXCenerimod Phase 3 Est. Readout
  • Mar 2027~IVBXFfulzerasib Phase 2 Est. Readout
  • Q1 2027~QRHHBYEnglumafusp alfa Phase 2 Est. Readout
  • Mar 2027~CLDXHuman CMV pp65-LAMP mRNA-pulsed autologous DCs Phase 2 Est. Readout
  • Mar 2027~RHHBYAtezolizumab Phase 3 Est. Readout
  • Mar 2027~RHHBYTrastuzumab Emtansine Phase 3 Est. Readout
  • Mar 2027~MSCLFSAT-3247 Phase 2 Est. Readout
  • Mar 2027~HURAIFx-Hu2.0 Phase 3 Est. Readout
  • Mar 31CGENData Readout — COM701
  • Q1 2027~QMRKPosaconazole IV 6 mg/kg Phase 2 Est. Readout
  • Q1 2027~QINVAVI-0609 Phase 2 Est. Readout
  • Mar 2027~CGONCretostimogene Grenadenorepvec Phase 2 Est. Readout
  • Q1 2027~QRHHBYSatralizumab Phase 3 Est. Readout
  • Q1 2027~QAZNAZD4360 Phase 2 Est. Readout
February 2027Full CalendarApril 2027

Get March Catalysts in Your Inbox

Subscribe to receive weekly digests of upcoming PDUFA dates and clinical trial results. Never miss an important FDA decision.

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.