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Checkpoint Therapeutics (NASDAQ:CKPT) said it has resubmitted its Biologics License Application to the FDA for its antibody treatment cosibelimab for the treatment of cutaneous squamous cell carcinoma, or cSCC.
The biotech company said it filed the resubmission after reaching alignment with the FDA regarding deficiencies outlined in a Complete Response Letter, or CRL, sent by the agency after it declined to approve the product last December. The CRL cited issues related to the company’s third-party contract manufacturing organization following an inspection.
Checkpoint is seeking to have cosibelimab approved for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
Earlier Tuesday, Checkpoint also announced it had entered into an agreement to raise $12M through a direct offering.