Biotech News

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

Replimune Group (REPL)Replimune GroupFDA / regulatory

WOBURN, Mass., April 10, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company received a complete response letter (CRL) from the U.S.

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Replimune Group

Oncolytic Immunotherapy Platform Replimune develops engineered herpes-simplex-virus-based immunotherapies that selectively replicate within tumors, directly destroy cancer cells, release tumor antigens, and stimulate systemic antitumor immunity. Its viruses are armed with immune-activating components intended to enhance local tumor...

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