FDA approves Checkpoint Thera’s Unloxcyt

US biotech Checkpoint Therapeutics (Nasdaq: CKPT) saw its shares jump more than 16% to $4.27 in after-hours trading on Friday, on the news of a first regulatory approval for the company.

The US Food and Drug Administration approved the firm’s Unloxcyt (cosibelimab-ipdl), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

Checkpoint noted that Unloxcyt is the first and only PD-L1 blocking antibody to receive FDA marketing approval for this indication. Last year, Checkpoint suffered a setback n the drug’s development, when the FDA issued a complete response letter (CRL), citing findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.