FDA Catalysts & Drug Pipeline

Track upcoming PDUFA dates, clinical trial readouts, and FDA advisory committees across 343+ biotech catalysts. Click any catalyst to view full details, dilution risk, and related signals.

Type:Sector:
Showing 50 of 343 catalysts
Ticker
Drug / Catalyst
Company
Type
Date
OCUL
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
Ocular Therapeutix
Phase 4
Jun 30, 2020
2210d ago
OCUL
The PRIME Study: A Randomized, Controlled, Prospective Study
Ocular Therapeutix
Phase 4
Aug 27, 2021
1787d ago
IRON
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Disc Medicine
Clinical Trial
May 18, 2023
1158d ago
IRON
Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
Disc Medicine
Clinical Trial
Feb 29, 2024
871d ago
SRPT
Defining Outcome Measures for Behavioural and Emotional Problems in Dystrophinopathies
Sarepta Therapeutics
Clinical Trial
Nov 19, 2024
607d ago
IRON
Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pa
Disc Medicine
Clinical Trial
May 23, 2025
422d ago
SGEN
Metastatic Breast Cancer in Austria
Seagen Inc
Clinical Trial
Jun 1, 2025
RYTM
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Rhythm Pharmaceuticals, Inc.
Phase 3
Jun 30, 2025
384d ago
AGIO
OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia
Agios Pharmaceuticals
Clinical Trial
Aug 30, 2025
323d ago
WVE
Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder
Wave Life Sciences Ltd.
Clinical Trial
Aug 31, 2025
322d ago
WVE
Effect of Electroacupuncture on Benign Prostatic Hyperplasia
Wave Life Sciences Ltd.
Clinical Trial
Sep 30, 2025
292d ago
WVE
Abertay Tea for Cardiovascular Health During Menopause
Wave Life Sciences Ltd.
Clinical Trial
Oct 1, 2025
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
UTHR
Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment
United Therapeutics
Clinical Trial
Dec 1, 2025
230d ago
RVMD
One-Minute Preceptor to Improve Bedside Teaching
Revolution Medicines
Clinical Trial
Dec 15, 2025
216d ago
WVE
Effects of Milk-based Drinks on Gut Microbiome, Sleep and Cardiometabolic Markers
Wave Life Sciences Ltd.
Clinical Trial
Mar 1, 2026
IRON
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Disc Medicine
Clinical Trial
Mar 31, 2026
110d ago
VNDA
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Vanda Pharmaceuticals
Phase 4
Mar 31, 2026
110d ago
OCUL
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Ocular Therapeutix
Phase 4
May 1, 2026
79d ago
IRON
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Ba
Disc Medicine
Phase 1
May 1, 2026
79d ago
TOI
Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cance
The Oncology Institute, Inc.
Phase 1
May 13, 2026
67d ago
IBRX
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
ImmunityBio, Inc.
Phase 1
May 15, 2026
65d ago
ADMA
Safety and Efficacy of Klotho and Follistatin Gene Therapy
ADMA Biologics
Early Phase 1
Jun 1, 2026
ZBIO
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
Zenas BioPharma, Inc.
Phase 2
Jun 1, 2026
VNDA
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Vanda Pharmaceuticals
Phase 3
Jun 1, 2026
VKTX
Observational Study for the Epidemiology of Cerebral Palsy in Italy
Viking Therapeutics
Clinical Trial
Jun 1, 2026
48d ago
VRTX
suzetrigine (VX-548)
moderate-to-severe acute pain sNDA
Vertex Pharmaceuticals
PDUFA
Jun 20, 2026
29d ago
ITCI
Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molec
Intra-Cellular Therapies
Clinical Trial
Jun 20, 2026
29d ago
PBYI
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Puma Biotechnology Inc
Phase 2
Jun 22, 2026
27d ago
IONS
donidalorsen
hereditary angioedema
Ionis Pharmaceuticals
PDUFA
Jun 25, 2026
24d ago
IMVT
batoclimab
thyroid eye disease
Immunovant Inc
PDUFA
Jun 28, 2026
21d ago
WVE
Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People
Wave Life Sciences Ltd.
Clinical Trial
Jun 30, 2026
19d ago
CMPS
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
COMPASS Pathways
Phase 3
Jun 30, 2026
19d ago
CMPX
BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe
Compass Therapeutics, Inc.
Clinical Trial
Jun 30, 2026
19d ago
AGIO
To Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopath
Agios Pharmaceuticals
Phase 2
Jun 30, 2026
19d ago
NUVL
zidesamtinib
ROS1+ NSCLC
Nuvalent Inc
PDUFA
Jun 30, 2026
19d ago
AXSM
Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder
Axsome Therapeutics
Phase 2
Jul 1, 2026
AMAG
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
AMAG Pharmaceuticals
Phase 3
Jul 1, 2026
AKBA
Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury
Akebia Therapeutics
Phase 2
Jul 1, 2026
18d ago
MRNA
mRNA-1283
RSV vaccine adult
Moderna Inc
PDUFA
Jul 8, 2026
11d ago
VKTX
VK2735
obesity subcutaneous
Viking Therapeutics
PDUFA
Jul 15, 2026
4d ago
NBIX
ingrezza (valbenazine)
Huntington's disease chorea sNDA
Neurocrine Biosciences
PDUFA
Jul 15, 2026
4d ago
EXEL
zanzalintinib
renal cell carcinoma
Exelixis Inc
PDUFA
Jul 20, 2026
in 1d
CLDX
barzolvolimab
chronic spontaneous urticaria
Celldex Therapeutics
PDUFA
Jul 22, 2026
in 3d
MRUS
zenocutuzumab
NRG1 fusion+ NSCLC/PDAC
Merus NV
PDUFA
Jul 25, 2026
in 6d
RCKT
beremagene geperpavec
dystrophic epidermolysis bullosa
Rocket Pharmaceuticals
PDUFA
Jul 28, 2026
in 9d
DCPH
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Deciphera Pharmaceuticals
Phase 1
Aug 1, 2026
VERV
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
Verve Therapeutics
Phase 1
Aug 1, 2026
RGNX
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
REGENXBIO Inc
Phase 2
Aug 1, 2026
ADMA
Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans
ADMA Biologics
Phase 1
Aug 1, 2026
Page 1 of 7

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.