Checkpoint Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission

  Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has reached alignment with the Food and Drug Administration (“FDA”) on its biologics license application (“BLA”) resubmission strategy for cosibelimab. 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.

https://www.biospace.com/article/releases/checkpoint-therapeutics-announces-alignment-with-fda-enabling-upcoming-cosibelimab-bla-resubmission/