Sarepta, FDA and gene therapy
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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.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
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.
There are about $10.5 billion of biotech convertibles outstanding, roughly 3% of the $305 billion market, according to BofA Securities.