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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

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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...

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