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The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU
EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory individuals with Duchenne muscular dystrophy (DMD) Roche will continue its ...
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Investor's Business Daily on MSNThe Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent.'Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety ...
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
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