Replimune Provides Update Following Type A Meeting with FDA

Core Viewpoint - Replimune Group, Inc. has completed a Type A meeting with the FDA regarding the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 and headquartered in Woburn, MA [4] - The company's lead product candidate, RP1 (vusolimogene oderparepvec), is engineered from a proprietary strain of herpes simplex virus designed to enhance tumor killing and activate systemic anti-tumor immune responses [3][4] FDA Interaction - The company is currently evaluating FDA feedback from the recent meeting to determine the next steps, with no clear path forward under the accelerated approval pathway established yet [2] - The CEO emphasized the unmet need in advanced melanoma and the favorable risk-benefit profile of RP1 observed in the IGNYTE trial, indicating a commitment to work with the FDA for a timely resolution [3]