Checkpoint Therapeutics

Aug 14, 2023

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Jun 30, 2023

Checkpoint Therapeutics Q2 2023 Earnings Report

Checkpoint Therapeutics' Q2 2023 financial results were reported.

Key Takeaways

Checkpoint Therapeutics reported its Q2 2023 financial results, highlighting the ongoing FDA review of the cosibelimab BLA with a PDUFA goal date of January 3, 2024, and successful completion of a mid-cycle meeting with the FDA. Longer-term data from pivotal studies of cosibelimab in cSCC demonstrated substantially increased complete response rates and a continued favorable safety profile.

The BLA for cosibelimab is under review by the U.S. FDA with a PDUFA goal date of January 3, 2024.

A successful mid-cycle meeting with the U.S. FDA was completed, with no significant review issues or safety concerns identified.

Longer-term cosibelimab results showed substantial increases in complete response rates in advanced cSCC patients.

Cosibelimab has the potential to address a large unmet clinical need in immunosuppressed and high-risk patients.