Analysts View 15% Drop in Sarepta Stock as a Buying Opportunity Following Delay of 9001 Decision

Shares of Sarepta Therapeutics (NASDAQ:SRPT) tumbled 15% in early Wednesday trading after the medical research company said the U.S. Food and Drug Administration (FDA) informed the company it “requires modest additional time to complete the review” of SRP-9001. The PDUFA date for ‘9001 will be delayed until June 22, 2023, from May 29th. The therapy is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD). The FDA also indicated that it intends to potentially grant an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old, once the review is completed. RBC analysts said the delay “offers concrete timelines” and believe the weakness presents a buying opportunity.