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

PHARPharming Group2026-09-25 14:30 EST

Pharming announces U.S. FDA acceptance and Priority Review of sNDA for lower doses of Joenja® to treat children with APDS

NTLAIntellia2026-09-08 12:00 EST

Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

PHARPharming Group2026-06-04 05:00 EST

Pharming announces U.S. FDA acceptance of sNDA resubmission for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS

RHHBYRoche Holdings AG2026-09-30 05:00 EST

Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis

RCKTRocket Pharmaceuticals2026-10-07 13:36 EST

Rocket Pharmaceuticals Highlights FDA-Aligned Pivotal Phase 2 Trial and Updated Clinical Findings for RP-A501 Following Danon Disease Investor Webinar

GSKGSK plc2026-08-24 07:01 EST

Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

SRPTSarepta Therapeutics2026-09-30 12:30 EST

Sarepta Therapeutics Presents New Data at 2026 World Muscle Society Annual Congress Demonstrating Safety and Clinically Meaningful Functional Benefit of ELEVIDYS (delandistrogene moxeparvovec) in Older Ambulatory Patients with Duchenne

ABEOAbeona Therapeutics2026-09-18 11:30 EST

Abeona Therapeutics® Congratulates Ultragenyx on U.S. FDA Approval of FAYUVI™ Gene Therapy for Sanfilippo Syndrome Type A (MPS IIIA)

SRPTSarepta Therapeutics2026-09-08 13:00 EST

Sarepta Therapeutics Announces Recipients of Route 79, The Duchenne Scholarship Program, for the 2026-2027 Academic Year

RHHBYRoche Holdings AG2026-09-10 05:00 EST

U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments

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