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FDA to Ask Sarepta to Halt Elevidys Shipments

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.

· 5h · on MSN

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

MSN · 2d

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

· 1d

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

Sarepta Therapeutics laid off more than one-third of its workforce, or approximately 500 employees, the company announced Wednesday — a drastic cost-cutting move following the deaths of two teenagers...

· 4h

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

· 9h

Sarepta shares slump on reports of third patient death this year

F.D.A. to Ask Biotech Company to Stop Shipping Treatment Linked to Patient Deaths

Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Elevidys, or a similar treatment.

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.

Sarepta shares slump after third patient death this year

Shares of Sarepta Therapeutics declined 17% in early trading on Friday after a patient who had received one of the company's experimental gene therapies died, deepening investor concern over the use of its treatments.

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