All articles tagged with #rp1
The FDA granted accelerated approval for Replimune's RP1 (brand Tudriqev) for advanced melanoma after an advisory panel backed efficacy signals despite concerns about trial design, ending a regulatory saga that included two prior rejections; the therapy is priced at $450,000 per course.
Replimune’s RP1 melanoma immunotherapy saw its shares jump about 107% after a FDA advisory committee voted 10-3 that the study results were valuable and clinically meaningful, a boost for accelerated approval prospects despite prior BLA denials in 2025; analysts subsequently upgraded the stock.
An FDA advisory committee voted 10-3 in favor of Replimune’s RP1 oncolytic virus (with Opdivo) for advanced melanoma, citing signs of efficacy despite significant trial-design concerns that the FDA flagged (no control arm, RECIST deviations, reinjection artifacts). While some data hint at systemic activity, the panel stressed uncertainty and noted the ongoing Ignyte-3 phase 3 data as pivotal; the FDA decision on RP1 is expected by August 2 amid a large unmet need for refractory melanoma treatments.
The FDA rejected Replimune’s RP1 melanoma candidate for a second time, citing that the Ignyte trial data do not show substantial evidence of effectiveness and that new trial data are unpersuasive (only about 10% of planned patients treated and no prespecified progression-free survival data). The agency’s ruling leaves RP1’s future uncertain and prompted a roughly 20% drop in Replimune’s stock.