Checkpoint Therapeutics Says Its Cosibelimab Not Approved

(RTTNews) - Checkpoint Therapeutics, Inc. (CKPT) Monday said the Food and Drug Administration (FDA) has declined to approve cosibelimab for the treatment of patients with cutaneous squamous cell carcinoma, citing issues with third-party contract manufacturing company.

The complete response letter did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab, Checkpoint said.

"As the only deficiencies relate to the FDA's inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024," said James Oliviero, President and Chief Executive Officer of Checkpoint.