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在FDA专员Makary辞职后，Replimune激增
2026-05-14 01:07
- Replimune (REPL), which has been critical of the FDA over its application for a melanoma treatment, is up ~30% Wednesday, the day after FDA Commissioner Marty Makary tendered his resignation.
- Makary left his position Tuesday amid reported pressure from President Trump who noted that he had been having "some difficulty" heading the agency. Many in the pharmaceutical and biotech industries were also unhappy with his leadership.
- Replimune is the latest biopharma to have a spat with the agency. In April, the FDA rejected its melanoma therapy, RP1, plummeting shares, even though the company included input in its application from a Type A meeting.
- Makary responded to the attack with an op-ed defending the agency's decision in The Wall Street Journal. However, the newspaper's editorial board also published an editorial lamenting some of Makary's actions.
- In a just-published piece, Seeking Alpha investing group Galzus Research is maintaining a cautious buy rating and sees a potential for an RP1 resubmission with Makary gone.
More on Replimune Group
- Replimune: Perhaps The FDA Shakeup Will Get A Mulligan For RP1
- Replimune: Second CRL May Have Sealed RP1's Fate - It's Hard To See Positives
- Replimune: Multiple Shots On Goal But A High Risk Binary Approaches
- FDA head Makary defends drug application rejections amid criticism
- RFK Jr. says no hand in rejecting Replimune’s lead asset
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