Replimune Group, Inc. announced its financial results for the fiscal second quarter ended December 31, 2024, along with a corporate update. The company confirmed the completion of its Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA).
Replimune stated it remained on track to submit a BLA for RP1 in combination with nivolumab for anti-PD1 failed melanoma via the accelerated approval pathway before the end of the calendar year. The confirmatory IGNYTE-3 trial for RP1 in advanced melanoma was also underway, with the first patient enrolled in August.
The company highlighted recent presentations of late-breaking abstracts at ESMO and SITC, which featured the primary analysis data from the IGNYTE trial. These presentations showcased clinical activity and initial biomarker analyses for RP1.
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