Replimune plans RP1 cancer drug resubmission after FDA talks
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Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA
May 29, 2026 8:00 AM EDTWOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA... More
