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FDA Requests Halt on Sarepta's Duchenne Gene Therapy Amid Safety Concerns

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Source: BioPharma Dive
FDA Requests Halt on Sarepta's Duchenne Gene Therapy Amid Safety Concerns
Photo: BioPharma Dive
TL;DR Summary

The FDA is expected to request Sarepta Therapeutics to halt shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, following safety concerns and patient deaths related to liver failure, which may lead to a market withdrawal amid ongoing safety investigations.

Topics:business#duchenne#elevidys#fda#gene-therapy#health#sarepta
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  1. FDA to ask Sarepta to stop shipping Duchenne gene therapy  BioPharma Dive
  2. Sarepta shares plunge 40% as future of its gene therapy appears at risk  CNBC
  3. FDA to Ask Sarepta to Stop Shipping Muscular Dystrophy Drug Elevidys  The New York Times
  4. Third death from a Sarepta gene therapy  biocentury.com
  5. We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress  STAT

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