Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy
On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).Sarepta Therapeutics, Inc. SRPT and Roche Holdings AG RHHBY are collaborating to develop and commercialize gene therapy.Also Read: Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revis ...