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FDA Panel Recommends Replimune’s RP1 for Melanoma, Decision Due 2026

8/1/2026

Summary

Panel Endorses RP1

The FDA advisory committee voted 10-3 to recommend RP1 with nivolumab for melanoma.
The panel said IGNYTE data were evaluable despite the single-arm, reporting a 34% response rate, 15% complete remission, median 24.8 months and survival of 32.9 months.
FDA reviewers noted a 15.7% response rate and a 14.1-month response, calling results difficult to interpret.
The agency must decide on the resubmitted Biologics License Application (BLA) by August 2, 2026.

Summary

Replimune Shows Runway

Replimune Group Inc. ended the quarter with $210.7 million in cash and $268.9 million when short-term investments are included, providing a solid runway before the August 2, 2026 PDUFA decision.
The quarter produced a net loss of $73.2 million and an operating cash outflow of $56.2 million.
Long-term debt stands at $107.5 million while a current ratio of 4.8 indicates short-term liquidity.
REPL trades at about 2.7 times its book value, reflecting market optionality for the RP1 program.

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Panel Endorses RP1

The FDA advisory committee voted 10-3 to recommend RP1 with nivolumab for melanoma.
The panel said IGNYTE data were evaluable despite the single-arm, reporting a 34% response rate, 15% complete remission, median 24.8 months and survival of 32.9 months.
FDA reviewers noted a 15.7% response rate and a 14.1-month response, calling results difficult to interpret.
The agency must decide on the resubmitted Biologics License Application (BLA) by August 2, 2026.

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