(Reuters) – The U.S. Food and Drug Administration has deferred an accelerated approval decision for Sarepta Therapeutics Inc’s gene therapy for a muscle wasting disorder to June 22 and needs more time to complete its review, the company said on Wednesday.
Shares of Sarepta were down 13% in premarket trading after the timeline for the treatment, SRP-9001, was deferred from May 29.The deferral followed a meeting of the regulator’s external advisers less than two weeks ago, where the panel narrowly backed an accelerated approval for the therapy with 8-6 votes.
(Reporting by Aditya Samal and Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)
