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FDA asks Sarepta to stop shipping gene therapy

Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics (SRPT.O) on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental trea...

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

· 22h · on MSN

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

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FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

A 51-year-old man died last month after receiving an experimental gene therapy developed by Sarepta Therapeutics for an ultra-rare form of muscular dystrophy, a company spokesperson confirmed Thursda...

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

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FDA to ask Sarepta to stop shipping Duchenne gene therapy

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Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys

Wall Street analysts have said the third death could amplify patient hesitancy to use Elevidys, given both the therapies use the same delivery vehicle known as adeno-associated virus vector.

STAT · 1d

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

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

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.

Hoodline21h

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

Inside an FDA drug rejection, and layoffs at Sarepta

Just how many employees is Sarepta Therapeutics laying off? And why did the FDA reject Ultragenyx's rare disease drug over manufacturing qualms?

1don MSN

Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.