Checkpoint Therapeutics, Inc. announced it has reached alignment with the Food and Drug Administration (FDA) on its biologics license application (BLA) resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or curative radiation. In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose during a multi- sponsor inspection of Checkpoint's third-party contract manufacturing organization ("CMO") as Approvability issues to address in a BLA resubmission.

The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.