FDA official sees ‘arduous’ path back for Sarepta’s Elevidys, STAT reports

An unnamed senior official at the FDA told STAT’s Adam Feuerstein and Jason Mast that Sarepta (SRPT) Therapeutics faces an “arduous and treacherous path” to get its gene therapy for Duchenne muscular dystrophy, Elevidys, back onto the market, which the publication sees “suggesting the treatment’s license could be revoked.” Informed of the comments, a Sarepta spokesperson told STAT the company had not been given the same message by its agency contacts, the report noted.