Checkpoint Therapeutics Inc. ( CKPT ) Checkpoint Therapeutics' investigational drug, Cosibelimab, is back at the FDA altar, awaiting a decision on December 28, 2024. Cosibelimab, an anti-programmed death ligand-1 ("PD-L1") antibody, is proposed for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. This is the company's second attempt to secure FDA approval for Cosibelimab. The U.S. regulatory agency had declined to approve Cosibelimab last December mainly due to inspection findings at a third-party manufacturer. No concerns about the clinical data package, safety, or labeling for the approvability of Cosibelimab were raised then, according to the company. Checkpoint was founded by Fortress Biotech, Inc. (FBIO). Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer, with more than 1 million cases diagnosed annually in the U.S.