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Sep 30, 2023
Checkpoint Therapeutics Q3 2023 Earnings Report
Announced third quarter 2023 financial results and recent corporate highlights.
Key Takeaways
Checkpoint Therapeutics reported their Q3 2023 financial results, highlighting the ongoing FDA review of the BLA for cosibelimab with a PDUFA goal date of January 3, 2024, and the recent publication of cosibelimab pivotal trial results in the Journal for ImmunoTherapy of Cancer.
FDA is reviewing the Biologics License Application for cosibelimab with a PDUFA goal date of January 3, 2024.
Pivotal trial results for cosibelimab in metastatic cutaneous squamous cell carcinoma were published in the Journal for ImmunoTherapy of Cancer.
Longer-term data from pivotal trials in locally advanced and metastatic cSCC demonstrate a deepening of response over time with higher complete response rates.
Checkpoint believes cosibelimab's clinical profile should position it as a preferred immunotherapy for oncologists, especially for difficult-to-treat cSCC patients.
Forward Guidance
The press release contains forward-looking statements regarding the FDA review of the BLA for cosibelimab, its commercial potential, differentiation, safety profile, mechanism of action, and projections of publication and regulatory review timelines.
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