Sarepta plans to seek traditional approval for DMD therapies

Sarepta Therapeutics plans to submit applications to convert Amondys 45 and Vyondys 53 from accelerated to traditional approvals for DMD. Wall Street analysts view this as a positive step that removes market withdrawal risks. The submission, supported by confirmatory trial data, strengthens the long-term outlook for these two Duchenne muscular dystrophy therapies.