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Sarepta quits enrolling for confirmatory Phase 3 trial of Elevidys

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Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys

Sarepta Therapeutics announced it will not enroll additional patients in the confirmatory Phase 3 trial of Elevidys, its Duchenne muscular dystrophy gene therapy, a study required to maintain the drug's accelerated approval.

Nov 6, 2026·2 sourcesClinical trial designDrug Policy, Pricing & ApprovalGene therapyPharmaceutical earningsDrug safetyClinical trialsGenetic diseasesAccelerated approval pathways
Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys
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Tech Times

Sarepta Closes Enrollment in Elevidys Phase 3 Trial, Leaving Non-Ambulatory Duchenne Patients Dependent on a 25-Person Safety Study