Full Press Release Details
SAN FRANCISCO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- The pending securities class action was triggered after news of safety problems with Sarepta’s (NASDAQ: SRPT) ELEVIDYS, a medication intended for the treatment of Duchenne muscular dystrophy.
The deadline for Sarepta investors with losses who wish to be considered by the court to serve as Lead Plaintiff is August 25, 2025. Accordingly, national shareholders rights firm Hagens Berman urges Sarepta investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys.
Class Period: June 22, 2023 – June 24, 2025
Lead Plaintiff Deadline: Aug. 25, 2025
Contact the Firm Now: SRPT@hbsslaw.com
European Regulators Reject Sarepta’s Gene Therapy for Duchenne
In a major setback for Sarepta Therapeutics, European drug regulators concluded last month that the company’s gene therapy, ELEVIDYS, failed to demonstrate clear benefits for patients with Duchenne muscular dystrophy—a rare and fatal muscle-wasting disorder that predominantly affects young boys.
On July 24, the European Medicines Agency released its formal statement: data from a pivotal trial involving 125 children ages 4 to 7 showed no significant difference in movement improvement between those who received ELEVIDYS and those who were given a placebo. Both groups registered modest gains in the North Star Ambulatory Assessment, the standard measure for motor function, but the agency found those changes to be statistically indistinguishable, dealing a blow to Sarepta’s efforts to expand the therapy’s reach in the European market.
The refusal underscores growing scrutiny over the effectiveness and safety of high-profile gene therapies approved in recent years. The EMA cited concerns about ELEVIDYS’ ability to deliver the promised improvements, even for patients who appeared most likely to benefit. While the product was developed as an orphan drug—an incentive for rare disease medicines—the agency ultimately determined Sarepta did not present sufficient evidence for a broader approval.
Sarepta Investor Class Action Lawsuit Alleges Misrepresentation
The regulatory defeat comes as Sarepta faces a securities class action lawsuit alleging that Sarepta made misleading statements about the prospects and development of ELEVIDYS.
More specifically, the complaint alleges the company misled investors by portraying ELEVIDYS as a safe and effective treatment with a clear path to broader regulatory approval, while withholding crucial information about significant safety risks to patients and that Sarepta knew the severity of these adverse events would likely lead to regulatory scrutiny, trial halts, and a greater risk to both current and expanded approvals for the drug.
Investors began to learn the truth on March 18, 2025, when Sarepta issued a safety update revealing that a non-ambulatory patient in an ELEVIDYS trial had died.
Then, on April 4, 2025, the company disclosed that EU authorities had requested a review of the patient death and that Sarepta had halted recruitment and dosing in some ELEVIDYS studies.
When, on June 15, 2025, a second death from acute liver failure in another non-ambulatory patient, Sarepta suspended shipments of ELEVIDYS for this patient group and pauses dosing in one of its clinical studies.
On June 24, 2025, the last day of the Class Period, the FDA issued a safety communication confirming its investigation into the risk of acute liver failure associated with ELEVIDYS treatment, citing the two reported deaths.
Each of these disclosures, the lawsuit contends, triggered a sharp drop in Sarepta's stock price.
Hagens Berman’s Investigation
“The EMA’s findings raise new questions about the disclosures Sarepta made to investors,” said Reed Kathrein, the Hagens Berman partner leading the investigation. “We are investigating whether the company’s statements about the drug’s efficacy and commercial prospects were misleading in light of this new information.”
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.
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.
Reed Kathrein, 844-916-0895