US EditionUS FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
UNITED STATES, JUL 18 – The FDA cited multiple patient deaths from acute liver failure linked to Elevidys, prompting a shipment halt to address safety concerns and ongoing investigation.
- On July 18, 2025, Sarepta received an informal FDA request to voluntarily halt ELEVIDYS shipments shortly after 2:30 p.m. ET, following safety concerns including patient deaths from acute liver failure.
- Amid mounting safety concerns after acute liver failure cases, shipments were paused last month for older Duchenne patients, and the FDA reported the ALF event to July 3, 2025, leading to the halt request.
- Reuters first reported the FDA's plans to request Sarepta halt Elevidys shipments, reflecting internal disagreements and an investigation into liver risks.
- On Friday, investors sent Sarepta's share price down more than 30%, reflecting the jeopardy to its business posed by the FDA's planned action.
- Amid this scrutiny, the company aims to work with regulators to maintain treatment availability, as the FDA is weighing full withdrawal of Elevidys, and Sarepta said it looks forward to continued discussions to safeguard patient safety and access.
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16 Articles
FDA Considering Pulling Gene Therapy From Market After Deaths: Commissioner
The Food and Drug Administration may revoke authorization for a gene therapy for which multiple deaths have been reported, the agency’s commissioner said on July 18. The FDA is “taking a hard look” at whether Sarepta Therapeutics’ Elevidys should remain on the market, Dr. Marty Makary told Bloomberg. Elevidys, a treatment for a rare form of muscular dystrophy called Duchenne muscular dystrophy, was approved after a previous top FDA official, Dr.…
US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.
Gene-therapy company to eliminate 21 Durham employees as part of major restructuring
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.
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