Sarepta, FDA and gene
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14hon MSN
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.
Roche Holding AG paused all shipments of the controversial gene therapy Elevidys following a similar action by the embattled US biotechnology company that developed the treatment.
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 will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
These were the most active stocks ahead of Friday's market open: Sarepta Therapeutics Inc.'s stock tumbled 27% after the company said another patient died following gene-therapy treatment, Bloomberg reported,
Shares of Sarepta Therapeutics declined 16.5% to $18.32 in premarket trading on Friday after a Bloomberg report that a patient enrolled in an early-stage study of one of the company's gene therapies has died from acute liver failure.