10:36 AM EDT, 06/24/2024 (MT Newswires) -- Checkpoint Therapeutics ( CKPT ) said Monday it plans to move forward with a mid-year resubmission of the biologics license application for its cosibelimab immunotherapy candidate to treat certain forms of skin cancer in patients who are not candidates for radiation treatment or surgery following recent discussions with US regulators.

The US Food and Drug Administration in December issued a complete response letter delaying its decision whether to approve cosibelimab for patients with metastatic or locally advanced cutaneous squamous cell carcinoma after a multi-sponsor inspection raised issues with the third-party contract manufacturing organization making cosibelimab for Checkpoint.

The FDA action late last year did raise any concerns about the clinical data, safety or labeling included with the biologics license application that would affect the agency's decision on whether to approve the new cancer treatment, the company said.

Checkpoint shares were nearly 4% higher in recent trading.

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