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Upcoming PDUFA Dates

Name: BiotechSign Upcoming PDUFA Dates
Creator: BiotechSign
License: https://biotechsign.com/terms

FDA approval decision deadlines for biotech drugs

20 Active Signals

NUVLNuvalent IncOncology

NUVL (Nuvalent Inc) — PDUFA date

57/100

RAREUltragenyx PharmaceuticalRare Disease

RARE (Ultragenyx Pharmaceutical) — PDUFA date

47/100

BTAIBioXcel TherapeuticsNeuroscience

IGALMI — BTAI PDUFA

41/100

INOInovio Pharmaceuticals, Inc.Biotech / Pharma

INO (Inovio Pharmaceuticals, Inc.) — PDUFA date

47/100

CAPRCapricor Therapeutics, Inc.Biotech / Pharma

CAPR (Capricor Therapeutics, Inc.) — PDUFA date

30/100

IONSIonis PharmaceuticalsAntisense Therapeutics

IONS (Ionis Pharmaceuticals) — PDUFA date

63/100

MLYSMineralys Therapeutics, Inc.Biotech / Pharma

Lorundrostat — Adults with Hypertension and Topline Explore-OSA Tr

27/100

VNDAVanda PharmaceuticalsNeuroscience

Generalized — VNDA PDUFA

50/100

CGEMCullinan OncologyOncology

Zipalertinib — CGEM PDUFA

25/100

PRAXPraxis Precision MedicineNeuroscience

PRAX (Praxis Precision Medicine) — PDUFA date

20/100

ARQTArcus BiosciencesImmuno-Oncology

ZORYVE — ARQT PDUFA

51/100

IBRXImmunityBio, Inc.Biotech / Pharma

IBRX (ImmunityBio, Inc.) — PDUFA date

50/100

CORTCorcept TherapeuticsEndocrinology

relacorilant — Cushing's syndrome

46/100

SMMTSummit Therapeutics Inc.Biotech / Pharma

Ivonescimab — SMMT PDUFA

48/100

INBXInhibrx IncOncology / Rare

Ozekibart — Conventional Chondrosarcoma No filing review issues

38/100

AXSMAxsome TherapeuticsNeuroscience

AXSM (Axsome Therapeutics) — PDUFA date

38/100

BBIOBridgeBio PharmaOncology

Encaleret — BBIO PDUFA

12/100

IMNMImmunome, Inc.Immunology

Varegacestat — IMNM PDUFA

25/100

PHVSPharvaris NVRare Disease

PHVS (Pharvaris NV) — PDUFA date

37/100

RPRXRoyalty Pharma plc Class ABiotech / Pharma

RPRX (Royalty Pharma plc Class A) — PDUFA date

7/100

Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.