1. Replimune faces a class action lawsuit for misleading investors about RP1. 2. FDA's rejection caused a 77% drop in Replimune's stock price. 3. Lawsuit claims Replimune overstated its drug's prospects and trial success. 4. Hagens Berman is investigating additional regulatory concerns regarding the IGNYTE trial. 5. The lead plaintiff deadline is September 22, 2025.
The 77% stock price crash post-FDA rejection indicates severe investor distrust and market reaction. Historical examples show class action lawsuits often result in prolonged negative sentiment and further price declines.
This lawsuit directly targets Replimune’s credibility and operations, heavily influencing market perceptions.
The ongoing lawsuit and potential regulatory scrutiny may affect investor confidence long-term. Similar cases often lead to sustained lower stock prices until resolved.
SAN FRANCISCO, Sept. 4, 2025 /PRNewswire/ -- A new securities class action lawsuit has been filed against Replimune Group, Inc. (NASDAQ:REPL) and its executives. The lawsuit alleges that the company misled investors by overstating the success of its lead cancer drug, RP1, leading to a massive 77% stock price crash after the FDA rejected its application.
The complaint, Jboor v. Replimune Group, Inc., is on behalf of investors who bought Replimune securities between November 22, 2024, and July 21, 2025.
Hagens Berman urges Replimune investors who suffered substantial losses to contact the firm 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
Did Replimune (REPL) Mislead Investors? Lawsuit Follows FDA Rejection
On July 22, 2025, Replimune publicly announced that the U.S. Food and Drug Administration (FDA) had issued a "Complete Response Letter" (CRL) for its Biologics License Application (BLA) for RP1. This letter effectively rejected the drug's approval for advanced melanoma. The news triggered a massive sell-off, causing the company's stock to plummet by 77% in a single day, wiping out billions in market value.
The lawsuit alleges that Replimune presented a misleadingly optimistic view of its drug's prospects. The complaint points to the FDA's CRL as evidence, stating that the IGNYTE trial was not "a sufficiently well-designed or controlled investigation" to provide substantial evidence of effectiveness.
Investor Lawsuit Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate
The lawsuit claims that Replimune failed to disclose that:
These previously undisclosed regulatory concerns led directly to the stock's dramatic collapse, resulting in significant losses for investors.
Hagens Berman's Investigation
National plaintiffs' rights law firm Hagens Berman is actively investigating whether Replimune misled its investors.
"Our investigation is centered on the IGNYTE trial—the very foundation of Replimune's application. The FDA's rejection letter stated the trial was not 'well-designed,' citing issues like patient heterogeneity and flawed design. These are not minor technicalities; they go to the core of the data's integrity. We're looking into whether management was aware of these fundamental weaknesses and failed to disclose them to investors who were banking on this approval."
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.
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SOURCE Hagens Berman Sobol Shapiro LLP