REPL LAWSUIT: Replimune Group, Inc. Sued for Fraud after FDA Response Letter – Contact BFA Law by September 22 Court Deadline (NASDAQ:REPL)

Core Viewpoint - A lawsuit has been filed against Replimune Group, Inc. and its senior executives for potential violations of federal securities laws, following a significant decline in stock price after the FDA's response regarding the company's lead product candidate RP1 [1][2][5]. Group 1: Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with its lead product candidate being RP1 for melanoma [3]. - The company announced positive results from its IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab on June 6, 2024, and subsequently submitted a biologics license application (BLA) to the FDA based on these results [3]. Group 2: Legal Issues - The lawsuit claims violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, representing investors who purchased Replimune securities [2]. - The complaint alleges that the IGNYTE Phase 1/2 trial design was inadequate to produce reliable results, despite the company promoting its outcomes [4]. Group 3: Stock Performance - Following the FDA's Complete Response Letter on July 22, 2025, which indicated that the IGNYTE trial was not considered adequate for substantial evidence of effectiveness, Replimune's stock price fell by more than 75% [5].