Checkpoint Therapeutics Q2 2023 Earnings Report
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.
Checkpoint Therapeutics
Checkpoint Therapeutics
Forward Guidance
Checkpoint Therapeutics is working towards the January 3, 2024 action date for its Biologics License Application for cosibelimab.