Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab's unique dual mechanism of action to patients suffering from cSCC." In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose d ...