FDA Extends Review For Sarepta Therapeutics' Duchenne Gene Therapy By Couple Of Weeks

The FDA informed Sarepta Therapeutics Inc SRPT that it requires modest additional time to complete the review of its SRP-9001 (delandistrogene moxeparvovec) for Duchenne muscular, including final label negotiations and postmarketing commitment discussions.
Last week, FDA's Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of Sarepta's SRP-9001.
The agency has extended the review date from May 29 to June 22.
Following discussions with FDA, the agency has indicated that subject to the completion of the BLA review, it is working toward potentially granting an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old.
EMBARK Phase 3 trial of SRP-9001 is the proposed confirmatory study.
Related: Sarepta Therapeutic Shares Surge 25% Following Favorable Gene Therapy Vote; Analyst Anticipates Huge Earnings Swing In 2024.
The agency has informed Sarepta that, in addition to confirming the results of the initial BLA approval, if the trial meets its objectives, the agency intends to entertain a non-age-restricted expansion of the SRP-9001 label based on the review of the EMBARK data.
EMBARK is fully enrolled, with top-line results expected in the fourth quarter of 2023.
Price Action: SRPT shares are down 9.44% at $133 on the last check Wednesday.