FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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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 announces layoffs of 493 employees, including 80 in Franklin County, amid restructuring efforts and criticism from the FDA.
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits seen in trials
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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Stocks on Sky High. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the top-performing companies on Thursday. Sarepta Therapeutics saw its share prices rise by 19.53 percent on Thursday to close at $21.
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Stocktwits on MSNSarepta Surges After-Hours As It Slashes 500 Jobs Amid FDA Black Box Warning For Gene Therapy — Retail Eyes ReboundSarepta Therapeutics shares surged 34% in after-hours trading on Wednesday after the company said it would slash 500 jobs, or 36% of its workforce, as part of its restructuring plan. The move is expected to decrease costs by $400 million annually starting in 2026,
Sarepta's cost-saving moves, FDA surprises, and pipeline potential position SRPT as a unique opportunity. Read here for an investment analysis.