Replimune Wins FDA Nod for Tudriqev After Roller-Coaster Run, Shares Dip

Replimune secures FDA clearance for Tudriqev, used with Opdivo to treat advanced melanoma, on its third submission after two prior denials. The approval, supported by an advisory panel’s positive vote, sets up the company for its first commercial launch, though the stock fell about 6% as investors weighed execution risk and the company’s regulatory history. Initial rollout targets ~200 early-adopter hospital accounts with full launch expected over the next year, and analysts see significant upside if Tudriqev captures a meaningful share of refractory melanoma—potentially $1B+ in annual sales—despite launch challenges and competition from Amgen and Iovance Biotherapeutics.