Sarepta Therapeutics said the U.S. FDA accepted for review its supplemental NDAs (sNDAs) for AMONDYS 45 and VYONDYS 53 for Duchenne muscular dystrophy. While acceptance is an early regulatory milestone with no efficacy/safety outcome disclosed, it is a positive step that can support continued upside expectations for the programs.
Sarepta Therapeutics said the U.S. FDA accepted for review its supplemental NDAs (sNDAs) for AMONDYS 45 and VYONDYS 53 for Duchenne muscular dystrophy. While acceptance is an early regulatory milestone with no efficacy/safety outcome disclosed, it is a positive step that can support continued upside expectations for the programs.
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