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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

FDA Will Ask Sarepta to Halt Gene Therapy Shipments After Deaths

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

CNBC on MSN · 5h

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.

Reuters on MSN · 3h

Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

Patient dies in Sarepta gene therapy trial, adding to safety concerns

The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the ...

STAT6h

Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more

In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...

11h

Friday's movers: Sarepta, Norfolk Southern, Netflix and more

These were the most active stocks ahead of Friday's market open: Sarepta Therapeutics Inc.'s stock tumbled 27% after the company said another patient died following gene-therapy treatment, Bloomberg ...

11h

Sarepta shares tumble after report of patient death in early-stage trial

Sarepta Therapeutics shares plunged premarket on Friday after the company disclosed another patient death linked to its gene therapy programs, this time during an early-stage trial for limb-girdle ...

Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting

The drastic cost-cutting move follows the deaths of two teenagers that forced the company to restrict usage of its gene ...

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