Biopharma · FDA Approvals · Stock
Compass Therapeutics Inc is a clinical-stage oncology-focused biopharmaceutical company that develops proprietary antibody therapeutics to engage the immune system to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. It is eng…
Assets on file: tovecimig
Dated catalysts for CMPX, including recently decided ones.
Every first-hand event for CMPX, newest first.
Compass Receives FDA Feedback Requiring Survival Trial for Tovecimig BLA in BTC
FDA recommended Compass conduct an additional trial demonstrating survival benefit before submitting a BLA for tovecimig in previously treated advanced BTC. Compass disagrees, citing positive ORR and PFS data from the Phase 2/3 COMPANION-002 study plus unmet need, and plans to engage further with the Agency while preparing the submission.
Compass reports positive Phase 2/3 topline for tovecimig in BTC
COMPANION-002 met its primary ORR endpoint (17.1% vs 5.3%, p=0.031) and showed a statistically significant PFS benefit (4.7 vs 2.6 months, HR=0.44). The company plans to meet with FDA in the coming months to discuss these data ahead of a planned BLA submission.
Companies in the same sector closest to CMPX in market value.