Checkpoint Therapeutics' Skin Cancer Therapy Rejected by FDA, Stock Plummets
The U.S. Food and Drug Administration (FDA) has declined to approve Checkpoint Therapeutics' experimental therapy, Cosibelimab, for the treatment of advanced skin cancer due to issues with a third-party contract manufacturer. The FDA did not express concerns about the drug's data or safety in its response letter. Checkpoint Therapeutics plans to address the feedback and resubmit the therapy for marketing approval in 2024. The trial data showed that Cosibelimab helped reduce or clear cancerous tumors by 47.4%.