Sarepta finalizes U.S. application for DMD med casimersen

Sarepta Therapeutics (NASDAQ:SRPT) completes its rolling New Drug Application (NDA) to the FDA seeking accelerated approval for casimersen (SRP-4045), for treatment of patients with Duchenne muscular dystrophy (DMD).

The NDA includes data from the casimersen arm of the ESSENCE study, evaluating efficacy and safety in patients amenable to skipping exons 45 and 53.

If accepted, the completed ESSENCE study will serve as a post-marketing confirmatory study.

https://seekingalpha.com/news/3586482-sarepta-finalizes-u-s-application-for-dmd-med-casimersen