FDA to Ask Sarepta to Halt Elevidys Shipments
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Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
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.
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.
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.
Sarepta agrees to FDA's black box warning and announces major restructuring, including job cuts and cost-saving measures to meet 2027 goals.
Sarepta Therapeutics stock soared over 30% after the pharmaceutical company said it would lay off about 500 employees. It will also add a black-box warning to its controversial gene therapy Elevidys.Shares of Sarepta were up 34% to $24.