FDA Catalysts & Drug Pipeline

Track upcoming PDUFA dates, clinical trial readouts, and FDA advisory committees across 25+ biotech catalysts. Click any catalyst to view full details, dilution risk, and related signals.

Type:Sector:
Showing 25 of 25 catalysts
Ticker
Drug / Catalyst
Company
Type
Date
NUVL
NUVL (Nuvalent Inc)
PDUFA date
Nuvalent Inc
PDUFAConfirmed
Sep 18, 2026
in 15d
RARE
RARE (Ultragenyx Pharmaceutical)
PDUFA date
Ultragenyx Pharmaceutical
PDUFAConfirmed
Sep 19, 2026
in 16d
IONS
IONS (Ionis Pharmaceuticals)
PDUFA date
Ionis Pharmaceuticals
PDUFAConfirmed
Sep 22, 2026
in 19d
INO
INO (Inovio Pharmaceuticals, Inc.)
PDUFA date
Inovio Pharmaceuticals, Inc.
PDUFAConfirmed
Oct 30, 2026
in 57d
SMMT
Ivonescimab
SMMT PDUFA
Summit Therapeutics Inc.
PDUFAConfirmed
Nov 14, 2026
in 72d
BTAI
IGALMI
BTAI PDUFA
BioXcel Therapeutics
PDUFAConfirmed
Nov 14, 2026
in 72d
CAPR
CAPR (Capricor Therapeutics, Inc.)
PDUFA date
Capricor Therapeutics, Inc.
PDUFAConfirmed
Nov 22, 2026
in 80d
VNDA
Generalized
VNDA PDUFA
Vanda Pharmaceuticals
PDUFAConfirmed
Dec 12, 2026
in 100d
CORT
relacorilant
Cushing's syndrome
Corcept Therapeutics
PDUFAExtracted
Dec 17, 2026
in 105d
MLYS
Lorundrostat
Adults with Hypertension and Topline Explore-OSA Tr
Mineralys Therapeutics, Inc.
PDUFAConfirmed
Dec 22, 2026
in 110d
IBRX
IBRX (ImmunityBio, Inc.)
PDUFA date
ImmunityBio, Inc.
PDUFAConfirmed
Jan 6, 2027
in 125d
PRAX
PRAX (Praxis Precision Medicine)
PDUFA date
Praxis Precision Medicine
PDUFAConfirmed
Jan 29, 2027
in 148d
ARQT
ZORYVE
ARQT PDUFA
Arcus Biosciences
PDUFAConfirmed
Feb 23, 2027
in 173d
CGEM
Zipalertinib
CGEM PDUFA
Cullinan Oncology
PDUFAConfirmed
Feb 27, 2027
in 177d
INBX
Ozekibart
Conventional Chondrosarcoma No filing review issues
Inhibrx Inc
PDUFAConfirmed
Apr 14, 2027
in 223d
PHVS
PHVS (Pharvaris NV)
PDUFA date
Pharvaris NV
PDUFAConfirmed
Apr 23, 2027
in 232d
RPRX
RPRX (Royalty Pharma plc Class A)
PDUFA date
Royalty Pharma plc Class A
PDUFAConfirmed
Apr 23, 2027
in 232d
IMNM
Varegacestat
IMNM PDUFA
Immunome, Inc.
PDUFAConfirmed
Apr 28, 2027
in 237d
AXSM
AXSM (Axsome Therapeutics)
PDUFA date
Axsome Therapeutics
PDUFAConfirmed
May 1, 2027
in 240d
BBIO
Encaleret
BBIO PDUFA
BridgeBio Pharma
PDUFAConfirmed
May 8, 2027
in 247d
RARE
Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Cor
Ultragenyx Pharmaceutical
Clinical Trial
Sep 1, 2027
RARE
Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency
Ultragenyx Pharmaceutical
Phase 1
Dec 31, 2028
in 850d
RARE
Phase I/II/III Gene Transfer Clinical Trial of scAAV9.U1a.hSGSH
Ultragenyx Pharmaceutical
Phase 2
Mar 1, 2029
RARE
Mucopolysaccharidosis VII Disease Monitoring Program
Ultragenyx Pharmaceutical
Clinical Trial
Apr 1, 2032
RARE
Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program
Ultragenyx Pharmaceutical
Clinical Trial
Dec 1, 2036

Understanding FDA Catalysts

FDA catalysts are regulatory events that can significantly impact biotech stock prices. The most important catalyst types include PDUFA dates (Prescription Drug User Fee Act deadlines), AdCom meetings (FDA Advisory Committee meetings), and clinical trial readouts (Phase 1, 2, and 3 data releases).

BiotechSign tracks all upcoming catalysts across 800+ biotech and pharmaceutical companies, providing real-time monitoring of FDA decisions, insider trading activity, dilution risk, and more. Use this page to identify upcoming catalysts and click through to individual pages for detailed analysis.

Not financial advice. Biotech investing involves binary FDA outcomes that can result in total loss. Data by Guerilla Finance Inc. for informational purposes only. Always conduct your own due diligence.

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