Replimune RP1 melanoma BLA wins favorable 10-3 FDA advisory panel vote on IGNYTE efficacy data

REPL•2026-07-30

FDA advisory panel backs IGNYTE efficacy package

Replimune’s RP1 melanoma filing cleared a key FDA advisory committee hurdle, with a 10-3 vote backing the IGNYTE efficacy package as evaluable.

Results were already reviewed at the meeting, supporting RP1 with nivolumab for patients whose disease progressed on prior anti-PD-1 therapy.

Panel discussion focused on whether the single-arm study supports a reliable, clinically meaningful benefit with signs of systemic anti-tumor activity.

FDA target action date for the Class 1 resubmission is Aug. 2, 2026, setting a near-term catalyst for the stock.

Replimune RP1 melanoma BLA wins favorable 10-3 FDA advisory panel vote on IGNYTE efficacy data

FDA advisory panel backs IGNYTE efficacy package

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