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Sarepta, FDA

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

U.S. regulators recently asked Sarepta Therapeutics to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died...

· 12h · on MSN

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

· 2d · on MSN

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

· 7h

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following s...

· 9h

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

STAT · 13h

In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

BioSpace10h

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.

MedPage Today1d

Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying the agency was investigating the three deaths due to acute liver failure following treatment with Sarepta's AAVrh74 gene therapies.

4don MSN

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta Therapeutics Inc. after two patient deaths, adding pressure to the biotech company which also announced a third patient had recently died on a similar treatment.