Sarepta plans regulatory submissions for two Duchenne drugs by April 2026
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Sarepta Provides Regulatory Update on AMONDYS 45® and VYONDYS 53®
March 19, 2026 8:30 AM EDTFollowing feedback from FDA, Company intends to submit supplemental new drug applications to FDA by the end of April 2026 requesting conversion to traditional approval
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided an update on its ongoing regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding AMONDYS 45® (casimersen) and VYONDYS 53® (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD).
Sarepta requested a meeting with FDA to discuss submitting supplemental new drug applications (sNDA) seeking... More
