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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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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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Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
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
FDA to ask Sarepta to stop shipping Duchenne gene therapy
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.

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Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
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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.
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.
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