Sarepta Therapeutics (SRPT) Announces Restructuring and ELEVIDYS Black Box Warning, EMA Recommends Refusal of Marketing Authorization, Securities Class Action Pending – Hagens Berman

SAN FRANCISCO, Aug. 01, 2025 (GLOBE NEWSWIRE) -- On July 16, 2025, Sarepta Therapeutics (NASDAQ: SRPT) announced a major restructuring that involves, in part, a 36% workforce reduction (500 employees) and other steps to annually save about $400 million. The company also agreed with the FDA to include a black box warning of acute liver injury and acute liver failure in Sarepta’s ELEVIDYS label. ELEVIDYS is the company’s gene therapy drug intended to treat a limited category of people with Duchenne muscular dystrophy.

The development comes in the wake of a securities class action styled Dolgicer v. Sarepta Therapeutics, Inc., et al., No. 1:25-cv-05317 (S.D.N.Y.), which seeks to represent investors who purchased or otherwise acquired Sarepta securities between June 22, 2023 and June 24, 2025.

National shareholders rights firm Hagens Berman continues to investigate the lawsuit’s legal claims and 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
Visit: www.hbsslaw.com/investor-fraud/srpt
Contact the Firm Now: SRPT@hbsslaw.com | 844-916-0895

Sarepta Therapeutics, Inc. (SRPT) Securities Class Action

The lawsuit challenges the safety and efficacy disclosures made by Sarepta regarding its gene therapy, ELEVIDYS. The complaint, filed on behalf of investors, alleges the company misled them by portraying ELEVIDYS as a safe and effective treatment with a clear path to broader regulatory approval, while withholding crucial information about significant risks.

According to the lawsuit, Sarepta conditioned investors to believe the therapy was ready for wider use without disclosing several key facts. The complaint claims the company failed to reveal that ELEVIDYS posed significant safety risks to patients and that its clinical trial protocols were inadequate to detect severe side effects. Furthermore, the lawsuit alleges 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.

The complaint outlines a timeline where investors say they began to learn the truth. On March 18, 2025, 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. A second death was announced on June 15, 2025, from acute liver failure in another non-ambulatory patient. This led Sarepta to suspend shipments of ELEVIDYS for this patient group and pause dosing in one of its clinical studies.

Finally, on June 24, 2025, 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. The complaint alleges these events prove that Sarepta's prior statements were false and misleading, and that the company failed to disclose material information to investors.

Sarepta Faces New Scrutiny as European Regulators Question ELEVIDYS’s Efficacy

After the filing of the complaint, on July 25, 2025, Investor’s Business Daily reported that the European Medicines Agency (“EMA”) rejected ELEVIDYS due to effectiveness questions. According to IBD, “[p]atients didn’t show a statistically significant benefit on North Star Ambulatory Assessment a year after their gene therapy infusion[,]” explaining that “NSAA measures functional motor skills in ambulant children with Duchenne muscular dystrophy[.]” This news drove the price of Sarepta shares significantly lower again.

Hagens Berman’s Investigation

“We’re investigating whether Sarepta may have misled investors about the safety and efficacy of—and potential future revenues from—its muscular dystrophy gene therapies,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

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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