Replimune(US:REPL) Globenewswireยท2025-09-21 15:20Core Viewpoint - Replimune Group, Inc. experienced a significant stock price decline of approximately 45% following the announcement of an FDA meeting regarding its Biologics License Application for the drug candidate RP1, with no clear path for accelerated approval established [1] Group 1: FDA Interaction and Stock Impact - On September 16, 2025, Replimune completed a Type A meeting with the FDA to discuss its BLA for RP1, but the FDA did not determine a path forward for accelerated approval [1] - The company's stock plummeted by 77% on July 22, 2025, after the FDA issued a Complete Response Letter rejecting the BLA for RP1, resulting in billions in market value loss [2] - The lawsuit against Replimune claims that the company misled investors about the success of RP1, contributing to the dramatic stock price drop [3][4] Group 2: Legal Proceedings and Allegations - A securities class action lawsuit has been filed against Replimune, with a lead plaintiff deadline set for September 22, 2025, urging affected investors to come forward [2] - The lawsuit alleges that Replimune failed to disclose regulatory concerns that directly led to the stock's collapse, resulting in significant investor losses [4] - Hagens Berman is investigating whether Replimune misrepresented the prospects of the IGNYTE trial, which was deemed inadequately designed by the FDA [5][6] Group 3: Trial Concerns and Management Accountability - The FDA's rejection letter highlighted that the IGNYTE trial was not well-designed, citing issues such as patient heterogeneity and flawed design, which are critical to the integrity of the data [6][7] - The lawsuit claims that Replimune overstated the likelihood of success for the IGNYTE trial, which the FDA found inadequate for approval [7] - The investigation is focused on whether Replimune's management was aware of the trial's fundamental flaws and failed to disclose this information to investors [6]