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:
Key Takeaways Sarepta Therapeutics shares were down nearly 25% early Friday morning.The tumble followed a report that a third patient has died during a clinical trial for its Elevidys drug that treats muscular dystrophy.
Sarepta Therapeutics (SRPT) said a third patient has died from acute liver failure after receiving one of its gene therapies, intensifying scrutiny over the safety of its treatments, Bloomberg reported.
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.
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.
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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.
The favorable market reaction indicates investor relief at management’s swift measures to rectify the company's worsening financial situation.
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.