Other Events ·
On September 22, 2026, Compass Therapeutics disclosed regulatory feedback from the FDA regarding its investigational…
CMPXCompass Therapeutics, Inc.
On September 22, 2026, Compass Therapeutics disclosed regulatory feedback from the FDA regarding its investigational drug tovecimig for previously treated advanced biliary tract cancer. The FDA recommended that the company conduct a new trial demonstrating a survival benefit prior to submitting a Biologics License Application (BLA). Compass disagrees with this requirement, citing statistically significant improvements in objective response rate and progression-free survival from the Phase 2/3 COMPANION-002 study, and intends to continue preparing for BLA submission while engaging with the agency. The company operates as a clinical-stage oncology-focused biopharmaceutical company developing antibody-based therapeutics.