Replimune (REPL) Faces Investor Lawsuit Following 77% Stock Crash After FDA Rejects Key Drug - Hagens Berman

Core Viewpoint - Replimune Group, Inc. faces a securities class action lawsuit following the FDA's rejection of its cancer drug RP1, which led to a significant drop in stock value and allegations of misleading investors regarding trial data and regulatory risks [1][2][3]. Group 1: Lawsuit Details - The lawsuit, Jboor v. Replimune Group, Inc., represents investors who purchased Replimune securities between November 22, 2024, and July 21, 2025, with a lead plaintiff deadline set for September 22, 2025 [2]. - The FDA issued a Complete Response Letter (CRL) on July 22, 2025, halting the approval process for RP1, which was intended for advanced melanoma treatment [2][5]. Group 2: Market Reaction - Following the FDA's announcement, Replimune's stock plummeted by 77% in a single day, resulting in billions in lost market value [3]. Group 3: Allegations of Misleading Information - The lawsuit claims Replimune provided a false sense of security by emphasizing prior FDA designations and trial data while failing to disclose critical issues with the IGNYTE trial's design [4][7]. - The FDA's CRL indicated that the IGNYTE trial was not adequately designed to provide substantial evidence of effectiveness, which was not disclosed to investors [4][5]. Group 4: FDA's Rejection Reasons - The FDA's rejection was based on undisclosed methodological issues in the IGNYTE trial, including patient heterogeneity and flaws in the planned confirmatory trial [8][5]. - The agency found the patient population too varied to draw reliable conclusions about the drug's effectiveness and questioned the evaluation of individual contributions in combination therapy [8]. Group 5: Investigation by Hagens Berman - Hagens Berman is investigating whether Replimune misled investors about the FDA's concerns, emphasizing the importance of transparency when a company's valuation relies on a single trial [9].