Checkpoint Therapeutics Inc.'s investigational drug, cosibelimab, proposed for the treatment of advanced cutaneous squamous cell carcinoma (cSCC), is under review by the FDA, with a decision anticipated by December 28, 2024.
Advanced cutaneous squamous cell carcinoma is a serious form of skin cancer that can spread to other parts of the body, and there are limited treatment options for patients with this advanced disease.
Cosibelimab is an anti-PD-L1 antibody designed to help the immune system target and destroy cancer cells.
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.
If approved, cosibelimab could offer a new, differentiated treatment option for patients with advanced cSCC, potentially improving outcomes for this underserved patient population.
CKPT closed Wednesday (Dec. 11, 2024) trading at $3.98, up 1.27%. In after-hours trading, , the stock was up 1.01% at $4.02.
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