Sarepta, FDA and gene
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After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.
Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat Duchenne muscular dystrophy, Elevidys, in a reversal of its prior stance.
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.
Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in the wake of rising safety concerns about liver toxicity, adding to mounting challenges for the drugmaker.
We recently published 10 Big Names Get Slammed. Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) is one of the biggest losers on Monday. Arrowhead Pharmaceuticals fell by 12.23 percent on Monday to close at $14.
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Investor's Business Daily on MSNSarepta Tumbles On The 'Painful' Decision To Stop Selling ElevidysSarepta stock toppled Tuesday after the company said it would voluntarily stop all shipments of Elevidys, complying with the FDA's request.
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Kostas Biliouris, BMO Capital Markets biotech analyst, joins CNBC's 'Squawk on the Street' to discuss the latest details on Sarepta after the company declined the FDA's request to halt shipments of its gene therapy.