Replimune (REPL) Faces Securities Class Action Following Stock’s Collapse Amid FDA’s Rejection of Melanoma Drug – Hagens Berman

SAN FRANCISCO, Aug. 20, 2025 (GLOBE NEWSWIRE) -- A new securities class action has been initiated against Replimune Group, Inc. (NASDAQ: REPL) and certain executives, arising out of the company’s recent stock price collapse. The lawsuit, officially known as Jboor v. Replimune Group, Inc., et al., No. 1:25-cv-12085 (D. Mass.), is on behalf of investors who acquired Replimune securities between November 22, 2024, and July 21, 2025.

The legal action follows a dramatic one-day plunge in Replimune's stock, which plummeted by 77% on July 22, 2025. This sell-off was triggered by a stunning announcement from the company: the U.S. Food and Drug Administration (FDA) had issued a "Complete Response Letter" (CRL) for its Biologics License Application (BLA) for RP1. The investigational drug, intended to treat advanced melanoma in combination with nivolumab, had its approval path halted, sending shockwaves through the market.

Hagens Berman is investigating whether Replimune may have violated the U.S. securities laws. The firm urges Replimune investors who suffered substantial losses to submit your losses now.

Class Period: Nov. 22, 2024 – July 21, 2025
Lead Plaintiff Deadline: Sept. 22, 2025
Visit: www.hbsslaw.com/investor-fraud/repl
Contact the Firm Now: REPL@hbsslaw.com | 844-916-0895

The Core of the Allegations

The complaint alleges that Replimune misrepresented the strength of the clinical data supporting its RP1 application. Throughout the designated Class Period, the company had consistently projected a positive outlook, citing the FDA’s Breakthrough Therapy and Accelerated Approval designations. Management had also highlighted data from the IGNYTE study, claiming it demonstrated that "roughly one-third of patients are able to achieve durable response in a high unmet need setting." These statements, the lawsuit contends, fostered a misleading sense of confidence among investors.

The core claims of the lawsuit assert that Replimune made false and misleading statements by:

1. Recklessly overstating the likelihood of success for the IGNYTE trial.
2. Failing to disclose that the FDA was likely to find the IGNYTE trial's design and data inadequate.

The FDA's CRL confirmed these concerns. The letter stated that the IGNYTE trial was not considered a "sufficiently well-designed or controlled investigation to provide substantial evidence of effectiveness." This suggests fundamental flaws in the trial's methodology that were not disclosed to the public.

Why the FDA Rejected the Application

The FDA’s rejection was based on several critical issues identified in the CRL. Beyond the overall inadequacy of the IGNYTE trial, the agency also highlighted two specific problems:

• Patient Heterogeneity: The FDA noted that the patient population in the study was too varied, making it difficult to draw reliable conclusions about the drug’s efficacy. A diverse patient group can obscure a drug's true impact by introducing too many variables.
  
• Confirmatory Trial Design Flaws: The agency also pointed out issues with the proposed design of the necessary confirmatory trial. Specifically, the FDA questioned how the individual contributions of each component in the combination therapy could be properly evaluated, a standard requirement for combination drug approvals.
  

The lawsuit underscores that these regulatory concerns, which the company allegedly failed to disclose, led directly to the severe financial consequences for investors. While the FDA did not cite any safety issues with RP1, the CRL has effectively stalled the drug's path to market and has become the central focus of this legal dispute.

Hagens Berman’s Investigation

Prominent shareholder rights firm Hagens Berman is investigating whether Replimune may have misled investors about the IGNYTE study.

“Our investigation is focused on whether Replimune’s public statements accurately reflected the true issues with its IGNYTE trial,” said Reed Kathrein, the Hagens Berman partner leading the investigation. “We are looking into whether the company had a duty to disclose the potential design flaws and data limitations that ultimately led to the FDA's rejection.”

If you invested in Replimune 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 Replimune case and our investigation, read more.

Whistleblowers: Persons with non-public information regarding Replimune 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 REPL@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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