Replimune Group, Inc. announced its financial results for the fiscal fourth quarter and year ended March 31, 2025, on May 22, 2025. The company reported a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the full fiscal year, compared to net losses of $55.1 million and $215.8 million for the respective prior periods.
The Biologics License Application (BLA) priority review for RP1 plus nivolumab in advanced melanoma was proceeding on schedule, with manufacturing inspections and the late-cycle review meeting completed. Replimune's commercial organization is fully hired and prepared for the potential launch ahead of the July 22nd PDUFA date.
The company estimates approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S., with about 80% of these patients eligible for RP1 treatment. These treatments are expected to occur in an outpatient setting, not requiring hospitalization, which could facilitate broader adoption.
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