FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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The death comes four months after Sarepta acknowledged the death of a 16-year-old young man with Duchenne muscular dystrophy following treatment with its marketed gene therapy Elevidys® (delandistrogene moxeparvovec-rokl), and just over a month after the ...
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm downgrading SRPT stock from Hold to Sell.
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
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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Asianet Newsable on MSNSarepta Draws Wall Street Ire After Third Patient Death This Year: Analyst Says ‘Deeply Concerning’ The Incident Wasn’t Reported EarlierA company spokesperson told Bloomberg that a 51-year-old patient died of acute liver failure last month in an early-stage trial of a gene therapy to treat limb-girdle muscular dystrophy.
Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene therapy pipeline this year, further clouding investor confidence despite the company’s recent efforts to provide clarity on its restructuring and FDA label plans.