FDA Will Ask Sarepta to Halt Gene Therapy Shipments
Digest more
Shares of Sarepta Therapeutics declined 17% in early trading on Friday after another patient who had received an experimental gene therapy died, deepening investor concerns over the use of the company's treatments.
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.
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.
Three patients with a muscle-wasting disease died from liver failure after taking the therapy, Elevidys, or a similar treatment.
Explore more
One of biotech’s highest fliers, Sarepta Therapeutics, lost more than a third of its market value on Friday after executives said that one of its experimental gene-replacement therapies was linked to the death of a 51-year-old man last month who received the treatment in a clinical trial.
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.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: