Replimune Announces Positive Pre-BLA Meeting with FDA and Confirms BLA Submission On Track for 2H 2024

WOBURN, Mass., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced it has completed a successful pre-Biologics License Application (pre-BLA) meeting with the U.S. Food and Drug Administration (FDA) that supports the Company’s plans to submit a BLA for RP1 (vusolimogene oderparepvec) for the treatment of anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024.