Checkpoint Therapeutics plans to resubmit BLA for cosibelimab mid-year, seeking FDA approval for cutaneous squamous cell carcinoma treatment.

Checkpoint Therapeutics plans to resubmit its BLA for cosibelimab mid-year, seeking FDA approval as a potential treatment for metastatic or locally advanced cutaneous squamous cell carcinoma patients not eligible for curative surgery or radiation. The company has reached alignment with the FDA on the resubmission strategy, addressing all approvability deficiencies outlined in the initial CRL.