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
FDA+
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
Why Is Replimune Stock Gaining Monday? - Replimune Group (NASDAQ:REPL)
Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more
Replimune, Dell Technologies, NetApp And Other Big Stocks Moving Higher on Friday - Chagee Holdings (NASD
Outlook moves toward potential US nod for thrice-snubbed eye drug with FDA appeal win
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
Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more…
Replimune Group (REPL) shares gain on key RP2 & RP1 oncology data presentations at ASCO. Read the clinical trial results.
Pharma updates from the Pharmalot campus via the Pharmalittle newsletter
