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Benzinga
Benzinga
Business
Vandana Singh

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

Elevidys Sarepta Gene Therapy EMA CHMP FDA The European Medicines Agency United States Arrowhead Embark
Konskie,,Poland,-,February,24,,2024:,Sarepta,Therapeutics,Company,Logo

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. (NASDAQ:SRPT) and Roche Holdings AG (OTC:RHHBY) are collaborating to develop and commercialize gene therapy.

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