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Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European ...
Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.
Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
Elevidys is the first gene therapy approved in the U.S. for the rare muscle-wasting condition, but it has faced scrutiny since its accelerated approval in 2023. Related Articles.
Sarepta Therapeutics (NASDAQ:SRPT) fell ~38% in the premarket on Monday after the company reported a second fatality from acute liver failure in a patient treated with Elevidys, a gene therapy ...
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...
The death of a second teenage boy from liver failure caused by a gene therapy from Sarepta Therapeutics has left the Duchenne muscular dystrophy community angry, fearful, and divided over whether ...