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FDA Panel Backs Melanoma Combo, Shares Double

8/1/2026

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Summary

Story summary

FDA advisory committee voted 10-3 on July 30 2026 that RP1 + nivolumab is “evaluable and clinically meaningful” for advanced melanoma.
The panel’s recommendation could trigger accelerated approval on August 2 2026, with IGNYTE reporting a 34% response rate and 15% complete remission.
After the vote, Replimune’s shares more than doubled to about $12.30 in after-hours trading, valuing the company at roughly $455 million.

History

Historical Context

James P. Allison’s anti-CTLA-4 research led Medarex, bought by Bristol-Myers Squibb in 2009, to develop ipilimumab, which the FDA approved in March 2011 after a phase III trial showed median survival of ten months versus 6.4 months with a vaccine. That first checkpoint-inhibitor approval created the accelerated-approval pathway now used for Replimune’s RP1-nivolumab combination.

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Story summary

FDA advisory committee voted 10-3 on July 30 2026 that RP1 + nivolumab is “evaluable and clinically meaningful” for advanced melanoma.
The panel’s recommendation could trigger accelerated approval on August 2 2026, with IGNYTE reporting a 34% response rate and 15% complete remission.
After the vote, Replimune’s shares more than doubled to about $12.30 in after-hours trading, valuing the company at roughly $455 million.

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