FDA accepts Sarepta's applications to convert two DMD drugs to full approval
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Sarepta Announces FDA Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®
June 30, 2026 8:30 AM EDTAccepted for review with target action date of February 28, 2027
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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 for filing the supplemental New Drug Applications (sNDAs) for AMONDYS 45® (casimersen) and VYONDYS 53® (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action data of February 28, 2027.
The sNDA submissions seek conversion of the accelerated approvals of AMONDYS 45 and... More
