Replimune surges after FDA advisers back skin cancer drug

Replimune shares more than doubled premarket after an FDA advisory panel voted 10-3 to back trial results for its melanoma drug RP1.
The panel found patient benefit despite FDA staff warnings that trial design flaws may have inflated response rates.
Replimune is seeking accelerated approval of RP1 combined with Bristol Myers Squibb’s Opdivo for refractory melanoma, and the FDA’s decision is due by Aug. 2.