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CMPX Compass Therapeutics

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

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Sep 22, 2026
12:30 PM
CMPXCompass Therapeutics

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.

Apr 27, 2026
11:30 AM
CMPXCompass Therapeutics

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.

Topline resultsSEC 8-KOpen record1 update

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CMPX FDA Calendar & Catalysts — Compass Therapeutics | Biopharma · FDA Approvals | SimianX AI