FDA Catalysts & Drug Pipeline

Track upcoming PDUFA dates, clinical trial readouts, and FDA advisory committees across 362+ biotech catalysts. Click any catalyst to view full details, dilution risk, and related signals.

Type:Sector:
Showing 50 of 362 catalysts
Ticker
Drug / Catalyst
Company
Type
Date
WCG
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction W
PharmaLex
Phase 3
Dec 1, 2024
BEAM
Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas
Beam Therapeutics
Clinical Trial
Feb 1, 2025
488d ago
WCG
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investi
PharmaLex
Clinical Trial
Mar 31, 2025
430d ago
SAGE
Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices
Sage Therapeutics
Clinical Trial
Apr 19, 2025
411d ago
IRON
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
Disc Medicine
Clinical Trial
Apr 28, 2025
402d ago
OM
Older Breast Cancer Patients: Risk for Cognitive Decline
Outset Medical, Inc.
Clinical Trial
Apr 30, 2025
400d ago
BEAM
Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management
Beam Therapeutics
Clinical Trial
May 1, 2025
SANA
First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes
Sana Biotechnology
Early Phase 1
May 1, 2025
CAI
Metastatic Breast Cancer in Austria
Caris Life Sciences, Inc.
Clinical Trial
Jun 1, 2025
COLL
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Collegium Pharmaceutical, Inc.
Phase 2
Jun 30, 2025
339d ago
NTRA
Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection
Natera Inc
Clinical Trial
Jul 31, 2025
308d ago
DAWN
Effects of Low-level Laser Therapy on Soft and Hard Tissue Healing After Impacted Mandibular Third Molar Extraction
Day One Biopharmaceuticals
Clinical Trial
Aug 30, 2025
278d ago
AGIO
OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia
Agios Pharmaceuticals
Clinical Trial
Aug 30, 2025
278d ago
PMN
Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness H
ProMIS Neurosciences
Clinical Trial
Sep 1, 2025
276d ago
TARS
The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals W
Tarsus Pharmaceuticals, Inc.
Clinical Trial
Oct 15, 2025
232d ago
AMAG
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
AMAG Pharmaceuticals
Phase 3
Nov 1, 2025
BEAT
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Heartbeam, Inc.
Clinical Trial
Nov 1, 2025
MIST
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Milestone Medical
Phase 2
Nov 30, 2025
186d ago
DYN
Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Po
Dyne Therapeutics
Clinical Trial
Dec 1, 2025
185d ago
STOK
Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission
Stoke Therapeutics
Clinical Trial
Dec 20, 2025
166d ago
GH
Biomarkers for Risk Stratification in Lung Cancer
Guardant Health
Clinical Trial
Dec 31, 2025
155d ago
BOLD
Effects of Photobiomodularion on Brain Connectivity and Cognitive Function in Cognitive Impairment
Bold Therapeutics
Clinical Trial
Dec 31, 2025
155d ago
GLUE
A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated
Monte Rosa Therapeutics
Phase 1
Jan 1, 2026
BOLD
Pramipexole to Enhance Social Connections
Bold Therapeutics
Phase 2
Mar 1, 2026
IRD
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Dec
Opus Genetics, Inc.
Phase 3
Mar 1, 2026
GH
Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain
Guardant Health
Clinical Trial
Mar 28, 2026
68d ago
IP
Validation Study of the Italian Version of the "Assessment of Life Habits 4.0" Scale (LIFE-H) for Measuring Participatio
International Paper Company
Clinical Trial
Apr 1, 2026
CARA
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Cara Therapeutics
Phase 2
Apr 30, 2026
35d ago
CARA
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endo
Cara Therapeutics
Phase 1
Apr 30, 2026
35d ago
STOK
OrthoPureXT Multiligament PMCF Study
Stoke Therapeutics
Clinical Trial
May 1, 2026
PRN
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Profound Medical
Phase 2
May 1, 2026
SMA
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
Spectral Medical
Early Phase 1
May 1, 2026
GH
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Guardant Health
Phase 2
May 1, 2026
PFE
marstacimab
hemophilia A/B
Pfizer Inc
PDUFA
May 10, 2026
25d ago
ACAD
pimavanserin
Alzheimer's disease psychosis
ACADIA Pharmaceuticals
PDUFA
May 10, 2026
25d ago
PRAX
PRAX-114
major depressive disorder
Praxis Precision Medicine
PDUFA
May 18, 2026
17d ago
ALNY
vutrisiran (Amvuttra)
ATTR polyneuropathy sNDA
Alnylam Pharmaceuticals
PDUFA
May 22, 2026
13d ago
GMAB
teclistamab
relapsed/refractory multiple myeloma
Genmab A/S
PDUFA
May 28, 2026
7d ago
GILD
lenacapavir
HIV PrEP
Gilead Sciences
PDUFA
May 30, 2026
5d ago
IPSC
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
Century Therapeutics, Inc.
Clinical Trial
May 31, 2026
4d ago
ADMA
Safety and Efficacy of Klotho and Follistatin Gene Therapy
ADMA Biologics
Early Phase 1
Jun 1, 2026
WCG
A First-in-Human Study of PRD001
PharmaLex
Phase 1
Jun 1, 2026
IMNM
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Immunome, Inc.
Phase 1
Jun 1, 2026
HCA
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
HCA Healthcare, Inc.
Clinical Trial
Jun 1, 2026
PMN
Comparing Single-Session Therapies for Chronic Pain
ProMIS Neurosciences
Clinical Trial
Jun 1, 2026
SION
Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2
Sionna Therapeutics, Inc.
Phase 1
Jun 1, 2026
INCY
povorcitinib
hidradenitis suppurativa
Incyte Corporation
PDUFA
Jun 5, 2026
in 1d
REGN
fianlimab
adjuvant melanoma
Regeneron Pharmaceuticals
PDUFA
Jun 12, 2026
in 8d
BEAM
BEAM-101
sickle cell disease
Beam Therapeutics
PDUFA
Jun 15, 2026
in 11d
MRNA
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations
Moderna Inc
Phase 4
Jun 19, 2026
in 15d
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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).

BiotechSigns 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.