Shares of the company for precision genetic medicine for rare diseases, Sarepta Therapeutics (NASDAQ: SRPT) jumped in pre-market trading at the time of publishing on Monday after the company’s SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulatory patients with Duchenne muscular dystrophy received a nod from the U.S. FDA for accelerated approval.
The FDA’s Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in favor of accelerated approval for the drug and the vote “while not binding, will be considered by the FDA when making its decision regarding the potential accelerated approval of SRP-9001. The Biologics License Application (BLA) for SRP-9001 is currently under priority review by the FDA with a regulatory action date of May 29, 2023.”
Analysts are bullish about SRPT stock with a Strong Buy consensus rating based on 19 Buys and three Holds.