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FDA to Ask Sarepta to Halt Elevidys Shipments

· 40m · on MSN

FDA to Ask Sarepta to Halt Elevidys 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.

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· 55m · on MSN

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

Sarepta to cut 500 jobs after gene therapy setback, shares jump

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

The U.S. Food and Drug Administration will request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

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

Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

5h

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 company’s transparency.

1mon

Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures

The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.

1mon

Biotech pauses trial after second patient death linked to gene therapy

Sarepta Therapeutics said a second patient had died after receiving its $3.2 million gene therapy to treat Duchenne muscular dystrophy.

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Food and Drug Administration