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LOS ANGELES, Aug. 19, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Sarepta Therapeutics, Inc. ("Sarepta Therapeutics" or the "Company") (NASDAQ: SRPT) investors of a class action representing investors that bought securities between June 22, 2023 and June 24, 2025, inclusive (the "Class Period"). Sarepta Therapeutics investors have until August 25, 2025 to file a lead plaintiff motion.
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
CASE ALLEGATIONS: Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for Duchenne muscular dystrophy (“Duchenne”), including its gene therapy product ELEVIDYS, designed for a limited subset of Duchenne patients.
According to the class action lawsuit, during the Class Period, Sarepta made false or misleading statements and/or failed to disclose material information, including that:
(i) ELEVIDYS presented significant safety risks to patients;
(ii) the clinical trial protocols for ELEVIDYS were inadequate to detect severe side effects; and
(iii) the occurrence and severity of adverse events would ultimately force Sarepta to pause recruitment and dosing in trials, trigger regulatory scrutiny, and jeopardize current and potential future approvals of the therapy.
The Complaint alleges that on March 18, 2025, Sarepta disclosed that a patient treated with ELEVIDYS had died from acute liver failure—described as “a severity of acute liver injury not previously reported” for the therapy. Following the news, Sarepta’s stock dropped more than 27%.
On April 4, 2025, Sarepta revealed that European regulatory authorities had requested a review of the incident by an independent data monitoring committee, resulting in the company halting recruitment and dosing in certain ELEVIDYS clinical trials. This announcement caused the stock to fall an additional 7%, according to the Complaint.
Then, on June 15, 2025, Sarepta announced a second patient death due to acute liver failure following ELEVIDYS treatment. In response, Sarepta suspended shipments of ELEVIDYS for non-ambulatory patients and paused dosing in the ENVISION study to re-evaluate its protocol in consultation with the FDA. The stock price reportedly declined over 42% on this news.
Finally, on June 24, 2025, the FDA issued a Safety Communication confirming it had received two reports of patient deaths and was investigating the potential for acute liver failure and serious outcomes associated with ELEVIDYS. Sarepta’s stock fell an additional 8% in response, according to the Complaint.
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