On June 24, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported it has reached alignment with the Food and Drug Administration ("FDA") on its biologics license application ("BLA") resubmission strategy for cosibelimab (Press release, Checkpoint Therapeutics, JUN 24, 2024, View Source [SID1234644497]). 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.

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We’re pleased to have reached alignment with the FDA on our BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter ("CRL") received last December. We’re eager to resubmit our BLA and to potentially bring a new and potentially differentiated immunotherapy treatment option to patients with advanced cSCC."

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.