Sarepta Therapeutics Inc (NASDAQ:SRPT) shares took a beating Thursday as Stat News reported that reviewers at the US Food and Drug Administration (FDA) were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by the company.
The “non-binding conclusion" prompted FDA official Peter Marks to intervene earlier this year and schedule an advisory meeting on May 12, Stat said citing three people with direct knowledge of the agency deliberations.
Investors reacted to the news, sending Sarepta shares down 6.07% to $129.32 in morning trade.
Similarly, shares of Catalent Inc, which holds the contract manufacturing rights for the therapy, fell nearly 1.4% to $63.35.
Cambridge, Massachusetts-based Sarepta is focused on engineering precision genetic medicine for rare diseases that devastate lives.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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