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Sarepta Therapeutics, Elevidys and European Medicines Agency
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The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
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.
European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
(RTTNews) - Shares of Sarepta Therapeutics Inc. (SRPT) are down over 37% at $22 in premarket trading Monday, following a second fatal case linked to its Duchenne gene therapy ELEVIDYS.
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
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 ...
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 ...
How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene ...
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