Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab

Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage company specializing in immunotherapy and targeted oncology, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for cosibelimab.

This anti-PD-L1 antibody is proposed as a treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not eligible for curative surgery or radiation. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024, for the review.

James F. Oliviero, President and CEO of Checkpoint, expressed satisfaction with the FDA's acceptance of the BLA resubmission, viewing it as a complete response following alignment on the resubmission strategy. He emphasized the company’s eagerness to collaborate with the FDA to complete the review process and potentially provide cosibelimab's dual mechanism of action to cSCC patients.

In December 2023, the FDA issued a Complete Response Letter (CRL) for the cosibelimab BLA, highlighting issues found during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization (CMO). These issues were the only concerns mentioned that were standing against its approval, with no objections raised regarding the clinical data, safety, or labelling of cosibelimab.