FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we never asked to join — said goodbye to their sons, the babies they once held in their arms, whose dreams they held in their hearts until Duchenne robbed them of working muscles or a healthy future.
The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm downgrading SRPT stock from Hold to Sell.
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
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.
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Asianet Newsable on MSNSarepta Draws Wall Street Ire After Third Patient Death This Year: Analyst Says ‘Deeply Concerning’ The Incident Wasn’t Reported EarlierA company spokesperson told Bloomberg that a 51-year-old patient died of acute liver failure last month in an early-stage trial of a gene therapy to treat limb-girdle muscular dystrophy.
Sarepta Therapeutics stock soared over 30% after the pharmaceutical company said it would lay off about 500 employees. It will also add a black-box warning to its controversial gene therapy Elevidys.Shares of Sarepta were up 34% to $24.
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.