Sarepta Therapeutics, Duchenne
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Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy
Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the treatment’s license could be revoked amid ongoing safety concerns.
Sarepta's pause on its prescription gene therapy drug for Duchenne muscular dystrophy gives the company time to work with the FDA on reviews. Infusions nationwide will be canceled. Also in the news, AstraZeneca,
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular dystrophy over safety issues, even as patients and investors expressed growing concern about the company’s decision-making.
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
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NBC4 WCMH-TV on MSNSarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in ColumbusSarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location. According to a mass layoff notice filed with the state, biotech company Sarepta Therapeutics laid off 80 employees Friday in central Ohio.
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
Sarepta Therapeutics to lay off 493 workers, including 80 in Ohio, amid FDA probe, stock plunge, and concerns over Duchenne gene therapy Elevidys.
Sarepta has not yet announced a plan to address the FDA’s concerns about its drug, but said it plans to meet with the FDA before the end of the year, according to STAT. Sarepta’s stock price ...