– Following feedback from FDA, Company intends to submit supplemental new drug applications to FDA by the end of April 2026 requesting conversion to traditional approval

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 conversion of the accelerated approvals of AMONDYS 45 and VYONDYS 53 to traditional approvals. This request was supported by data from the ESSENCE confirmatory study; substantial, published real-world evidence supporting treatment; and the favorable safety profiles of both therapies. Sarepta has received feedback from the Agency confirming that we can submit our data from ESSENCE and real-world evidence as part of the sNDAs. The adequacy of the data to support conversion to traditional approval will be a matter of review. The Company intends to submit the sNDAs by the end of April.