SAN FRANCISCO, Aug. 22, 2025 (GLOBE NEWSWIRE) — A securities class-action lawsuit is underway against Sarepta Therapeutics (NASDAQ: SRPT), triggered by a series of safety concerns and regulatory setbacks for its gene therapy, ELEVIDYS. The lawsuit alleges that Sarepta misled investors by presenting ELEVIDYS as a safe and effective treatment with a clear path to broader regulatory approval.
The deadline for investors with losses to be considered by the court to serve as Lead Plaintiff is August 25, 2025. Hagens Berman urges Sarepta investors who suffered substantial losses to submit your losses now.
Class Period: June 22, 2023 – June 24, 2025
Lead Plaintiff Deadline: Aug. 25, 2025
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Timeline of Disclosures and Stock Drops
According to the lawsuit, investors learned about the drug’s safety issues in a series of events that caused a sharp decline in Sarepta’s stock price.
- March 18, 2025: Sarepta announced a patient death in an ELEVIDYS trial.
- April 4, 2025: The company disclosed that EU authorities were reviewing the patient death, leading to a halt in some clinical studies.
- June 15, 2025: A second patient death from acute liver failure was reported, prompting Sarepta to suspend shipments for certain patient groups.
- June 24, 2025: The FDA issued a safety communication confirming its own investigation into the risk of acute liver failure associated with ELEVIDYS.
European Regulators Reject ELEVIDYS
Adding to the company’s challenges, European drug regulators recently rejected ELEVIDYS. On July 24, the European Medicines Agency (EMA) concluded that a key trial involving 125 children showed no significant difference in movement improvement between patients who received the gene therapy and those who received a placebo. This decision deals a major blow to Sarepta’s plans to expand its presence in the European market and puts the spotlight on the effectiveness and safety of high-profile gene therapies.
Hagens Berman’s Investigation
National shareholder rights firm Hagens Berman is investigating the claims on behalf of investors who suffered substantial losses. The firm is encouraging anyone with knowledge of the matter to come forward and assist with the investigation.
Reed Kathrein, the Hagens Berman partner leading the investigation, commented on the situation, “Sarepta’s stock price has been hit repeatedly by safety and regulatory news, culminating in the EMA’s rejection of ELEVIDYS. We are investigating whether the company’s prior statements and clinical trial protocols adequately reflected the significant risks to both patients and the drug’s approval process.”
If you invested in Sarepta and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to frequently asked questions about the Sarepta case and our investigation, read more »
Whistleblowers: Persons with non-public information regarding Sarepta should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email SRPT@hbsslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Contact:
Reed Kathrein, 844-916-0895
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