FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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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.
Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Elevidys, or a similar treatment.
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.
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.
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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.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
Stocks traded mixed Friday as investors focused on corporate earnings, a day after the S&P 500 and Nasdaq Composite set record closing highs.These stocks were making moves Friday:Second-quarter profit at Netflix rose 46% to $3.