Sarepta Therapeutics, Inc. (SRPT) Securities Class Action

Sarepta Therapeutics, Inc. (SRPT) Securities Class Action:

The lawsuit is focused on the propriety of Sarepta’s safety and efficacy disclosures about ELEVIDYS, a prescription gene therapy intended to treat a limited category of people with Duchenne muscular dystrophy.

More specifically, the lawsuit contends that Sarepta conditioned investors to believe that ELEVIDYS was a safe therapy that could be expanded for wider application approval and positioned ELEVIDYS as having no hinderances to broader use.

The complaint alleges that Sarepta made false and misleading statements while failing to disclose material information to investors, including:

• ELEVIDYS posed significant safety risks to patients;
• ELEVIDYS trial regimes and protocols failed to detect severe side effects; and
• The severity of adverse events from ELEVIDYS would cause Sarepta to halt patient recruitment and dosing in ELEVIDYS trials, attract regulatory scrutiny, and create greater risk around the therapy’s present and expanded approvals.

Investors began to learn the truth on March 18, 2025, when Sarepta issued a safety update on ELEVIDYS and revealed that a non-ambulatory patient being treated with the therapy died.

Then, on April 4, 2025, Sarepta disclosed that EU member country authorities requested that the independent data monitoring committee meet to review the patient death and that the company halted recruitment and dosing in some of its ELEVIDYS clinical studies.

Next, on June 15, 2025, Sarepta announced that a second non-ambulatory patient being treated with ELEVIDYS died from acute liver failure, it was suspending shipments of ELEVIDYS for non-ambulatory patients while it evaluated trial regimens and discussed findings with regulators, and it was pausing dosing in one of its ELEVIDYS clinical studies.

Finally, on June 24, 2025, the FDA issued a safety communication announcing its receipt of two death reports and its investigation into the risk of acute liver failure with serious outcomes following treatment with ELEVIDYS.

Each of these events triggered a steep decline in the price of Sarepta shares.

Sarepta Under Fire: New Death, FDA Clinical Hold, and Analyst Price Target Slash Following Post-Suit Developments

After the filing of the suit, on July 18, 2025, the financial press reported that in June 2025 a separate death occurred in a clinical trial of a different investigational gene therapy (SRP-9004) for limb-girdle muscular dystrophy. The company said it reported the death to the FDA on July 3, 2025.

Separately, the FDA concurrently announced that it placed Sarepta investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold after the three deaths and that Sarepta denied the FDA leadership’s request to halt all shipments of ELEVIDYS “today.”

In addition, H.C. Wainwright has reportedly reduced its price target for Sarepta to $0.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the SRPT investigation about?

We are investigating whether Sarepta may have misled investors about the safety of—and potential future revenues from—its muscular dystrophy gene therapies.

WHAT SHOULD I DO?

I worked at SRPT. What should I do?

If you were an employee of SRPT, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower 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, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in SRPT, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any SRPT investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.