Replimune will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty Makary; shares jumped about 70%.
May 29, 2026 11:07 AM EDT
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Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections
Max Bayer
Third time’s the charm?
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks
Replimune to resubmit melanoma drug RP1 after FDA shakeup
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Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more
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Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and…
Replimune wins accelerated FDA approval for RP1 in advanced melanoma after two rejections, despite data concerns. Drug combines…
A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance…
The FDA rejected vusolimogene oderparepvec twice under former Commissioner Marty Makary, who stepped down earlier this month
FDA staff criticized Replimune's RP1 melanoma drug ahead of an advisory meeting, saying its Phase 2 trial failed to prove…
The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier…
