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Replimune received FDA acceptance for its RP1 BLA resubmission in advanced melanoma, with a PDUFA date set for April 2026. REPL stock surged nearly 100% on the news, but FDA acceptance only restarts ...

FDA accepted Replimune’s resubmitted Biologics License Application for RP1 combined with Bristol Myers Squibb’s Opdivo to treat advanced melanoma The agency set April 10, 2026 as the decision deadline ...

The biotech received the good news it was hoping for from a top national regulator. This concerned RP1, its advanced melanoma drug. Well before market open, Replimune announced that the U.S. Food and ...

Shares of Replimune Group, Inc. (NASDAQ:REPL) are rising Monday after the clinical stage biotechnology company shared an important regulatory update. What To Know: Replimune said the U.S. Food and ...

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Replimune Group’s REPL share price tumbled 54.2% over the past three months. The massive setback was observed after the FDA issued a complete response letter (CRL) in July, against the biologics ...

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On July 22, 2025, Replimune publicly announced that the U.S. Food and Drug Administration (FDA) had issued a "Complete Response Letter" (CRL) for its Biologics License Application (BLA) for RP1. This ...