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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
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reut...

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FDA to ask Sarepta to stop shipping Duchenne gene therapy
Sarepta shares slump after third patient death this year
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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STAT · 1d
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
STAT1dOpinion
We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we never asked to join — said goodbye to their sons, the babies they once held in their arms, whose dreams they held in their hearts until Duchenne robbed them of working muscles or a healthy future.
Sarepta shares plunge 40% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.
80 employees at Columbus biotech facility to be laid off amid FDA scrutiny
Sarepta Therapeutics announces layoffs of 493 employees, including 80 in Franklin County, amid restructuring efforts and criticism from the FDA.
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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