Sarepta Seeks Broader Approval for Gene Therapy Even After Drug Trial Fizzled

  • Therapy for kids’ muscle disease hasn’t shown clear benefit
  • FDA’s accelerated approval pathway remains under scrutiny

A technician runs a test at a lab.

Photographer: Lauryn Ishak/Bloomberg
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Normally when a drug fails to show a clear effect in a final-stage trial, the company developing it goes back to the drawing board. But not Sarepta Therapeutics Inc.

Late Monday, the company said a trial of its $3.2 million gene therapy for Duchenne muscular dystrophy failed to clearly slow the disease in a year-long trial of 125 young kids with the progressive muscle-wasting disease. The company’s stock declined 37% Tuesday, wiping out $3.76 billion in market value.