Replimune Group, Inc. (REPL) Securities Class Action

The lawsuit is focused on the propriety of Replimune’s statements concerning data submitted to the FDA in support of its Biologics License Application (BLA).

Throughout the Class Period, Replimune had painted an optimistic picture for RP1, citing its Breakthrough Therapy designation by the FDA, its Accelerated Approval pathway, and assurances that "data from the IGNYTE study shows that roughly one-third of patients are able to achieve durable response in a high unmet need setting with few options." These in turn fueled hopes that RP1 could offer a crucial new treatment for a particularly aggressive form of skin cancer.

The complaint alleges that Replimune made false and misleading statements while failing to disclose that (1) the company recklessly overstated the IGNYTE trial’s prospects, and (2) the FDA was likely to deem the IGNYTE trial inadequate and not well-controlled.

Investors’ hopes for RP1 were severely dashed by its July 22nd announcement. Replimune revealed that the FDA's letter made it clear that the agency was "unable to approve the application in its present form." More critically, the FDA stated that the IGNYTE trial was not considered a sufficiently well-designed or controlled investigation to provide solid proof of the drug's effectiveness. This suggests fundamental issues with how the trial was conducted.

Furthermore, the FDA found that the trial's results could not be properly understood because of the wide variation in the patient population included in the study. Essentially, the patients in the trial were too different from each other, making it difficult to draw reliable conclusions about the drug's impact. The agency also pointed out problems with the design of the necessary confirmatory trial, including questions about how each component of the treatment contributed to the overall effect.

The market reacted swiftly, sending the price of Replimune shares crashing 77% lower on unusually high volume on July 22, 2025.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the REPL investigation about?

We are investigating whether Replimune may have misled investors about its IGNYTE trial design and data.

WHAT SHOULD I DO?

I worked at REPL. What should I do?

If you were an employee of REPL, 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 REPL, 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 REPL 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.