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![]() “We look forward to continuing to work closely with the FDA as we endeavor to bring cosibelimab to patients in need as quickly as possible. “The filing acceptance of our BLA is a major milestone for Checkpoint and our promising cosibelimab development program,” said James Oliviero, President and Chief Executive Officer of Checkpoint. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. Food and Drug Administration (“FDA”) has accepted for filing the Biologics License Application (“BLA”) for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or radiation. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Claim your 1-week free trial here.Ĭheckpoint Therapeutics, Inc. Get inside Wall Street with StreetInsider Premium. ![]() |
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