REPL CLASS ACTION ALERT: FDA Response Letter Leads to Replimune Group, Inc. Class Action – Investors are Notified to Contact BFA Law by September 22 Deadline

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]. Company Overview - Replimune Group, Inc. is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with its lead product candidate being RP1 for melanoma [3]. Clinical Trial and Regulatory Issues - The company announced positive results from the 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][4]. - However, the FDA issued a Complete Response Letter on July 22, 2025, stating that the IGNYTE trial was not considered adequate for demonstrating effectiveness due to the heterogeneity of the patient population [5]. Stock Performance - Following the FDA's announcement, Replimune's stock price fell by more than 75% on July 22, 2025, reflecting investor reaction to the negative regulatory feedback [5].