GlobeNewswire News Roomยท2025-08-27 20:19Core Viewpoint - Replimune Group, Inc. is facing a securities fraud class action lawsuit following a significant decline in its stock price after the FDA issued a Complete Response Letter regarding its lead product RP1, indicating inadequacies in the clinical trial [3][4]. Group 1: Company Overview - Replimune Group, Inc. is a biotechnology company focused on developing immunotherapy treatments, specifically for advanced melanoma [3]. - The company's lead product, RP1, was under review by the FDA in combination with nivolumab [3]. Group 2: Recent Developments - On July 22, 2025, Replimune announced it received a Complete Response Letter from the FDA, which stated that the IGNYTE trial was not considered adequate for demonstrating effectiveness [3]. - Following this announcement, Replimune's stock price fell by $9.52, or approximately 77.24%, closing at $2.81 per share [3]. Group 3: Legal Action - A class action lawsuit has been filed on behalf of investors who purchased Replimune securities between November 22, 2024, and July 21, 2025 [4]. - The lawsuit alleges that Replimune made false or misleading statements regarding the IGNYTE trial's prospects, leading to the FDA's negative assessment [4].