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Sarepta Woes Mount as Duchenne Gene Therapy Knocked Back in Europe

EUROPEAN UNION, JUL 25 – The European Medicines Agency's committee cited lack of clinical improvement and safety concerns, including patient deaths, in recommending against Elevidys approval for Duchenne muscular dystrophy.

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could further jeopardize Sarepta’s financial future.

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biopharmadive.com broke the news in on Friday, July 25, 2025.
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