Sarepta Says FDA Accepted Efficacy Supplement To BLA For Elevidys

(RTTNews) - Sarepta Therapeutics, Inc. (SRPT) announced on Friday that it has been granted Priority Review status by the FDA for its Efficacy Supplement to the Biologics License Application for Elevidys. Following this news, the stock rose 14% in the pre-market.

Sarepta stated that the Efficacy Supplement is intended to broaden the approved use of Elevidys for treating Duchenne muscular dystrophy or DMD patients with a confirmed mutation in the DMD gene and to transition the accelerated approval of Elevidys to a traditional approval.

The company disclosed that the target review goal date is scheduled for June 21, 2024, and the FDA has verified that there are no plans for an advisory committee meeting to deliberate on the supplement.

In pre-market activity on the Nasdaq, the shares were trading at $143.01, up 14.51%.