FDA Panel Backs Replimune's RP1 in 10-3 Vote as Shares Jump 127%
Updated
Updated · Yahoo Finance · Jul 31
FDA Panel Backs Replimune's RP1 in 10-3 Vote as Shares Jump 127%
3 articles · Updated · Yahoo Finance · Jul 31
Summary
A 10-3 FDA advisory panel vote found Replimune's RP1 data reliable and clinically meaningful for advanced melanoma patients whose disease progressed after prior anti-PD-1 therapy.
RP1 is a modified virus given with Bristol Myers Squibb's nivolumab, and advisers concluded the single-arm study was persuasive enough despite questions about trial design and durability of response.
Replimune shares surged 127% after hours, and the FDA is due to decide by Aug. 2 while a larger confirmatory trial continues.
RP1 had already been rejected twice, including in July 2025, when the FDA said the IGNYTE study was not an adequate well-controlled trial and could not clearly isolate RP1's benefit.