Sarepta Therapeutics will stop enrolling additional patients for the confirmatory Phase 3 trial of its Duchenne muscular dystrophy gene therapy Elevidys. The decision affects a study originally intended to provide confirmatory evidence for approval in older boys, according to the report. The move puts a renewed spotlight on confirmatory-evidence trials that follow breakthrough or accelerated pathways, and on how sponsors manage trial timelines against evolving regulatory expectations and patient-population definitions. For DMD stakeholders, the update also underscores the operational risk around late-stage enrollment and protocol targeting—particularly for registrational studies where incremental recruitment can materially change readout timing.
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