11:51 AM EDT, 07/25/2024 (MT Newswires) -- Checkpoint Therapeutics ( CKPT ) said Thursday that the US Food and Drug Administration has accepted for review its resubmission of the biologics license application for cosibelimab, with a Prescription Drug User Fee Act target date of Dec. 28.

Cosibelimab is a potential treatment of advanced cutaneous squamous cell carcinoma, a type of skin cancer, in adults who are not eligible for curative surgery or radiation, the drugmaker said.

The FDA's December 2023 complete response letter to the previous biologics license application cited certain issues related to its third-party contract manufacturing organization and did not identify concerns over the clinical data, safety, or labeling of cosibelimab, the company said.

Shares of Checkpoint were up 8.7% in recent trading.

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