Replimune receives FDA rejection for melanoma treatment RP1
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Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma
April 10, 2026 5:02 PM EDTWOBURN, 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. Food and Drug Administration (FDA) for the Companys Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.
Replimune disagrees with the FDA about whether the data set, upon which breakthrough therapy designation was awarded, is sufficient to allow this promising medicine to be made available to advanced... More
