Sarepta Therapeutics (SRPT) Declines Again On EMA Recommendation to Refuse ELEVIDYS Marketing Authorization, Securities Class Action Pending – Hagens Berman
SAN FRANCISCO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- On July 24, 2025, the European Medicines Agency (“EMA”) recommended the refusal of the marketing authorization for ELEVIDYS, Sarepta’s medication intended for the treatment of Duchenne muscular dystrophy. This news prompted another significant decline in the price of Sarepta (NASDAQ: SRPT) shares.
The EMA’s recommendation follows a slew of bad news for Sarepta investors, including patient deaths that resulted in sharp stock price declines, a securities class action (styled Dolgicer v. Sarepta Therapeutics, Inc., et al., No. 1:25-cv-05317 (S.D.N.Y.)), a major company restructuring that involves, in part, a 36% workforce reduction (500 employees) and other steps to annually save about $400 million, and the company’ agreement with the FDA to include a black box warning of acute liver injury and acute liver failure in Sarepta’s ELEVIDYS label.
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
The EMA Concluded That ELEVIDYS Lacks Efficacy:
On July 24, 2025, the EMA released a statement regarding ELEVIDYS. The agency reported that data from a key study involving 125 children between the ages of four and seven failed to demonstrate that the drug had a significant effect on movement abilities after a year. Improvements in North Star Ambulatory Assessment (NSAA) scores were observed in both the group that received ELEVIDYS and the placebo group. The EMA concluded that the difference in the change of NSAA scores between these two groups was not statistically significant.
Sarepta Therapeutics, Inc. (SRPT) Securities Class Action:
This disappointing news comes in the wake of a securities class action lawsuit filed by investors, who allege that Sarepta made misleading statements about the prospects and development of ELEVIDYS. 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 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.
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.
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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