Replimune Group (REPL) Nosedives 39% as FDA Approval for Melanoma Treatment ‘Uncertain’

Group 1 - Replimune Group, Inc. experienced a significant decline of 39.40%, closing at $3.46, following regulatory challenges for its melanoma treatment candidate [1][3] - The company met with the US FDA to discuss the complete response letter regarding its biologics license application for RP1, in combination with nivolumab, for advanced melanoma treatment [2] - The FDA's response left Replimune uncertain about the potential for accelerated approval of the drug [3] Group 2 - Replimune's CEO emphasized the unmet need in advanced melanoma and the favorable risk-benefit profile of RP1 observed in the IGNYTE trial, expressing commitment to work with the FDA for a path forward [4]