2 July 2024 - Checkpoint Therapeutics today announced it has completed the resubmission of its biologics license application to the US FDA for cosibelimab, its anti-programmed death ligand- antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

The biologics license application resubmission follows Checkpoint recently reaching alignment with the FDA on its resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter received last December, in which FDA only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.

Read Checkpoint Therapeutics press release