Investor Lawsuit Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate - Hagens Berman

Core Viewpoint - A securities class action lawsuit has been filed against Replimune Group, Inc. alleging that the company misled investors regarding the success of its cancer drug RP1, resulting in a 77% stock price crash after the FDA rejected its application [1][2]. 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 [1][2]. - The FDA issued a "Complete Response Letter" on July 22, 2025, rejecting the Biologics License Application for RP1, which led to a significant sell-off and a 77% decline in stock price [2][4]. Group 2: Allegations of Misleading Information - The lawsuit claims that Replimune presented an overly optimistic view of the drug's prospects, failing to disclose regulatory concerns that contributed to the stock's collapse [3][4]. - The FDA's rejection letter indicated that the IGNYTE trial was not "well-designed" and lacked substantial evidence of effectiveness due to issues such as patient heterogeneity and flawed design [6][7]. Group 3: Investigation and Implications - Hagens Berman is investigating whether Replimune misled investors about the IGNYTE trial, which was central to the drug's application [5][6]. - The investigation focuses on whether management was aware of the trial's fundamental weaknesses and did not disclose them to investors [6][7].