Sarepta Therapeutics (SRPT) shares fell more than 10% in Friday premarket trading after Europe's drug regulator recommended the refusal of marketing authorization for the company's Duchenne muscular dystrophy drug Elevidys.
Sarepta's partner outside the US, Roche said it will continue discussions with the European Medicines Agency to explore a potential way forward.
Roche said the benefit-risk profile of Elevidys remains positive for the ambulatory patient population.