Sarepta halts enrollment in confirmatory Elevidys trial

· Health · United States

Sarepta Therapeutics said it will stop enrolling patients in the Phase 3 trial of Elevidys, its gene therapy for Duchenne muscular dystrophy, a study meant to serve as confirmatory evidence for approval in older boys. The decision leaves the confirmatory program incomplete for a treatment already on the market, a sensitive position for a company whose gene therapy has drawn regulatory scrutiny. The move was reported by Endpoints News without further detail on timing or the number of patients already enrolled.

Why it matters：A stalled confirmatory trial could expose Sarepta to accelerated-approval withdrawal risk, a scenario increasingly watched across the gene therapy sector.

Key points

  • Enrollment is ending in the Phase 3 confirmatory study of Elevidys.
  • The trial was intended to support approval in older boys.
  • No further details on timing or enrollment numbers were given.

Sources (original reporting)

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