Sarepta Woes Mount as Duchenne Gene Therapy Knocked Back in Europe

Sarepta falls after it fails to get EU approval

Elevidys, which is marketed by Roche outside the US, accounts for half of the company’s revenue....

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Sarepta Therapeutics Acknowledges CHMP Negative Opinion for ELEVIDYS in the European Union

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 25, 2025-

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Sarepta woes mount as Duchenne gene therapy knocked back in Europe

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

CHMP rejects Elevidys in latest setback for Sarepta

Sarepta said it accepts the CHMP decision on Elevidys, while partner Roche said it will continue working with the EMA.