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Sarepta Therapeutics

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Roche to Run New Elevidys Trial for European Approval; FDA Plans Advisory Panels on Compounded PeptidesSubstrate placeholder — needs review · Wikimedia Commons (CC BY-SA 3.0)
health5 days ago

Roche to Run New Elevidys Trial for European Approval; FDA Plans Advisory Panels on Compounded Peptides

Roche announced a new trial of Elevidys, Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy, to pursue approval in Europe. Meanwhile, the FDA will hold advisory panel meetings starting July 2026 to reconsider restrictions on compounded peptides.

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Elevidys Gene Therapy Shows Positive Results in Duchenne Muscular Dystrophy TrialSubstrate placeholder — needs review · Wikimedia Commons (CC BY-SA 3.0)
science27 days ago

Elevidys Gene Therapy Shows Positive Results in Duchenne Muscular Dystrophy Trial

Sarepta Therapeutics reported positive topline results from a phase 3 trial of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial met its primary endpoint of improved motor function in patients aged 4 to 7. The Duchenne muscular dystrophy field has experienced s…

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