Shares of Sarepta Therapeutics, Inc. (SRPT) tanked over 24% on Tuesday morning after the company shared an update related to Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy. The company reported that a young man died following treatment with Elevidys, having suffered acute liver failure.
SRPT is currently trading at $76.77, down $24.58 or 24.25%, on the Nasdaq. The stock opened at $78.61 and closed Monday at $101.35. In the past 52 weeks, it has traded between $75.90 and $173.25.
Acute liver injury is a known possible side effect of Elevidys and other AAV-mediated gene therapies and is highlighted in the prescribing information.
Although it is not a new safety signal and the benefit-risk of Elevidys remains positive, acute liver failure (ALF) leading to death represents a severity of acute liver injury not previously reported for ELEVIDYS, which to date has been used to treat more than 800 patients in clinical trials or as a prescribed therapy.
In addition, testing revealed this patient had a recent cytomegalovirus (CMV) infection which was identified by the treating physician as a possible contributing factor. CMV can infect and damage the liver, a condition known as CMV hepatitis.
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