Development CostsReplimune guides to sufficient cash runway to fund operations into 4Q26, accounting for the costs associated with scaling up for the potential commercialization of RP1 in skin cancers.
Market CompetitionReplimune's RP1 + Opdivo combination therapy shows potential differentiation against other treatments like Amtagvi™ due to its efficacy and safety profile.
Regulatory ProcessThe FDA has accepted REPL's BLA for RP1 and granted priority review, with a PDUFA date set for July 22, 2025.