FDA to Ask Sarepta to Halt Elevidys Shipments
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Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Elevidys, or a similar treatment.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
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.
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
Shares of Sarepta Therapeutics plummeted nearly 30% premarket Friday following a report that a third patient has died during a clinical trial for one of its medications.
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.
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.
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.