FDA Shuts Down Sarepta Gene Therapy Trials
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Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.
Sarepta Therapeutics (NASDAQ:SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second session after plunging 36% on Friday. The decline follows the company's refusal to halt all shipments of its Elevidys gene therapy,
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Investor's Business Daily on MSNSarepta's 'Unprecedented Times' Continue As Company Rebukes The FDASarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments of Elevidys.
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
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.
A third patient has died this year after getting a gene therapy from Sarepta Therapeutics Inc., raising questions about the company’s transparency and adding more pressure on US regulators to decide on the future of the company’s most important drug.