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Investing.com -- Shares of Sarepta Therapeutics, Inc. (NASDAQ: NASDAQ:SRPT) plummeted 26% following the company’s online statement regarding a patient death associated with its gene therapy product, ELEVIDYS. The news of the incident, which involved acute liver failure in a patient treated with ELEVIDYS, has raised concerns among investors and contributed to the sharp decline in the company’s stock price.
Sarepta Therapeutics, a company specializing in precision genetic medicine for rare diseases, expressed deep sorrow over the loss of a young man with Duchenne muscular dystrophy who died after being treated with their gene therapy. Acute liver injury, as noted by the company, is a recognized potential side effect of ELEVIDYS and is documented in the therapy’s prescribing information. Although this type of severe liver injury leading to death has not been previously reported with ELEVIDYS, which has been administered to over 800 patients either in clinical trials or as a prescribed therapy, the incident has cast a shadow over the therapy’s safety profile.
The patient’s recent cytomegalovirus (CMV) infection was mentioned by the treating physician as a possible contributing factor to the liver failure. CMV hepatitis is known to cause liver damage and could have played a role in this case. Sarepta has emphasized that patient safety is their utmost concern and is actively working on gathering and analyzing information from this unfortunate event. The company has reported the incident to relevant health authorities and plans to update the ELEVIDYS prescribing information to reflect this occurrence. Additionally, the event has been communicated to clinical study investigators and physicians who prescribe the therapy.
The impact of this news on Sarepta’s stock underscores the sensitivity of biotechnology companies to safety concerns surrounding their products. Investors often react swiftly to any hint of risk associated with novel therapies, particularly when they result in patient harm. As Sarepta deals with the repercussions of this event, the market’s response serves as a reminder of the inherent challenges and responsibilities faced by developers of genetic medicines.
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