Biotech News

Sarepta Announces FDA Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®

Sarepta Therapeutics (SRPT)Sarepta TherapeuticsFDA / regulatory

– Accepted for review with target action date of February 28, 2027 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 30, 2026-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted

Related news

SRPTSarepta Therapeutics2026-03-19 12:30 EST

Sarepta Provides Regulatory Update on AMONDYS 45® and VYONDYS 53®

GSKGSK plc2026-04-28 12:00 EST

Bepirovirsen accepted for priority review and granted Breakthrough Therapy Designation by the US FDA

NTLAIntellia2026-04-27 11:00 EST

Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary Angioedema

SRPTSarepta Therapeutics2026-08-05 20:05 EST

Sarepta Therapeutics Announces Second Quarter 2026 Financial Results and Recent Corporate Developments

RCKTRocket Pharmaceuticals2026-03-27 11:00 EST

Rocket Pharmaceuticals Announces FDA Approval of KRESLADI™ for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I)

MGTXMeiraGTx2026-03-26 12:01 EST

MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports Fourth Quarter and Full Year 2025 Financial and Operational Results

KRYSKrystal Biotech2026-05-18 12:00 EST

Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa

GSKGSK plc2026-04-27 12:00 EST

GSK’s investigational liver therapy, efimosfermin, receives US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) designations for MASH

CRBUCaribou2026-03-31 12:01 EST

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy

VYGRVoyager Therapeutics2026-06-01 12:00 EST

Voyager Receives FDA IND Clearance for VY1706, First Gene Therapy Approach to Reducing Tau Production in the Brain for Alzheimer’s Disease

Sarepta Therapeutics

Precision Genetic Medicine Sarepta Therapeutics develops and commercializes genetic medicines for rare neuromuscular diseases, with a major focus on Duchenne muscular dystrophy. ELEVIDYS ELEVIDYS is an AAV-based gene-transfer therapy that delivers a micro-dystrophin transgene to skeletal muscle. It is indicated for ambulatory patients...

Recent company news

Stock data

Close
16.78 USD
Market cap
1.72B USD
Exchange
NASDAQ
Sector
Gene Therapy
Location
United States