Clinical Trial SuccessIGNYTE trial results support approval with an objective response rate of 33.6%, which is significantly higher than expected with anti-PD1 agents alone.
Financial StrengthReplimune ended the financial quarter with a strong cash position, providing an operational runway that extends into several key data catalysts and a potential market launch.
Regulatory ProgressThe FDA has accepted the resubmission of the Biologics License Application for RP1 + Opdivo for review, indicating progress towards potential approval.