Checkpoint Therapeutics Q4 2022 Earnings Report
Key Takeaways
Checkpoint Therapeutics announced the FDA accepted the BLA filing for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma with a PDUFA goal date of January 3, 2024. The initial indication for cosibelimab represents a potential $1.6 billion U.S. market opportunity.
FDA accepted for filing the Biologics License Application for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma.
PDUFA goal date of January 3, 2024.
Checkpoint submitted a BLA for metastatic and locally advanced cSCC in January 2023.
Olafertinib is being evaluated as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer.
Checkpoint Therapeutics
Checkpoint Therapeutics
Forward Guidance
The press release contains forward-looking statements regarding the FDA review of the BLA for cosibelimab, the commercial potential of cosibelimab, and the differentiation of cosibelimab.