11:04 AM EDT, 09/09/2024 (MT Newswires) -- Replimune Group ( REPL ) said Monday it is planning to submit a Biologics License Application for RP1 to the US Food and Drug Administration via the accelerated approval pathway in H2 after a "successful" pre-BLA meeting with the drug regulator.

RP1 is the company's lead product candidate to treat anti-PD1 failed melanoma, the clinical-stage biotechnology firm said. Topline results from the primary analysis of the RP1 plus nivolumab trial shared earlier this year showed an overall response rate of 33%.

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