Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
Roche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys available to individuals living with DMD in the EU Roche believes the benefit-risk remains positive in the ambulatory Duchenne population Elevidys is the first and only disease-modifying gene therapy for DMD Basel, 25 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that 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). Given the high unmet need in DMD, Roche plans to continue to work with the EMA to explore a potential path forward. "We are disappointed by the CHMP's negative opinion, given the urgent need for disease-modifying therapies for children in the EU living with Duchenne," said Levi Garraway, M.D.,
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