FDA Commissioner resignation sparks Replimune 21% surge on RP1 approval hopes

 

• Replimune’s stock rose ~20.9% on May 13, 2026, extending gains from an ~9% move on May 12 when Makary’s exit was announced/confirmed.
• Makary oversaw or defended two FDA Complete Response Letters rejecting RP1 (vusolimogene oderparepvec) + nivolumab for advanced melanoma (initial 2025 CRL and second in April 2026), citing insufficient evidence from the single-arm IGNYTE trial.
• The rejections triggered sharp prior declines (50–60% plunges), layoffs, and manufacturing scale-backs at Replimune; WSJ editorials heavily criticized the decisions as overly rigid.
• Traders and biotech investors view Makary’s departure (effective around May 12–13, via resignation per President Trump statements) as opening the door for new FDA leadership potentially more open to re-review, additional data, or accelerated approval pathways.
• High short interest (around 50% previously noted in context) amplified the move via short covering, alongside elevated volume and retail/forum momentum in small-cap biotech names.
• Broader sector lift was seen in related biotech stocks (e.g., QURE); no new Replimune-specific clinical data or company announcement drove the exact day’s move.
• Replimune has ASCO 2026 oral presentations scheduled for late May on RP1 melanoma data, providing additional context for renewed optimism.

https://finviz.com/quote?t=REPL&p=d