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FDA asks Sarepta to stop shipping gene therapy

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

MarketWatch · 3m

FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death

Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was linked to the deaths of two teenage boys earlier this year.

Benzinga · 44m

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.

2don MSN

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 to voluntarily stop all shipments of its gene therapy ...

Hoodline22h

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

STAT2d

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...

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 ...

Sarepta shares slump after report of patient death in early-stage study

Shares of Sarepta Therapeutics declined 16.5% to $18.32 in premarket trading on Friday after a Bloomberg report that a patient enrolled in an early-stage study of one of the company's gene therapies ...

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