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, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.
The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the company’s transparency.
Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died following treatment with a gene therapy, marking the third death linked to the company's experimental treatments.
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Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift, and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.