Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, Securities Class Action Pending - Hagens Berman

REPL Investors with Losses Encouraged to Contact the Firm Before Sept. 22nd Deadline

SAN FRANCISCO, Sept. 20, 2025 On September 18, 2025, investors in Replimune Group, Inc. (NASDAQ: REPL) saw the price of their shares crater about 45% during intraday trading after the company announced that it completed a Type A meeting with the FDA on September 16 to discuss its Biologics License Application ("BLA") for lead drug candidate RP1 but "a path forward under the accelerated approval pathway has not been determined." 

This development follows the filing of a securities class action lawsuit, which 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 Lead Plaintiff deadline in the case is September 22, 2025, and Hagens Berman urges investors in Replimune with 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: [email protected]
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:

• The company had overstated the likelihood of success for the IGNYTE trial.
• The FDA was likely to find the trial's design and data inadequate for approval.
• The trial had fundamental flaws, including a heterogeneous patient population, which made it difficult for the FDA to interpret the results. The agency also had issues with the design of the planned confirmatory trial.

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," said Reed Kathrein, the Hagens Berman partner leading the investigation.

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 [email protected].

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. 

SOURCE Hagens Berman Sobol Shapiro LLP