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?
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Replimune to resubmit melanoma drug RP1 after FDA shakeup
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Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and…
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
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US stocks up, Dow Jones up 171 pts. Replimune Group rises after FDA agreement. Other big gainers include Dell, NetApp, and Okta.
A third of patients in a clinical trial had tumors shrink while taking a genetically engineered treatment known as RP1.
