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.
Market ConfidenceAnalyst's recommendation to upgrade the stock to OP reflects renewed confidence following the FDA's acceptance and management's expressed confidence in the path forward.
Regulatory ApprovalThe FDA has accepted the resubmission of the Biologics License Application for RP1 + Opdivo for review, indicating progress towards potential approval.