Recent Updates — CMPX

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.

Compass Therapeutics reported a net loss of $25.2 million ($0.13 per share) for the quarter ended June 30, 2026, compared to $19.9 million in the prior year period. The company holds $180 million in cash and marketable securities, providing an anticipated runway into 2028. Pipeline updates include positive Phase 2/3 data for tovecimig in biliary tract cancer with an overall response rate of 18.0%, FDA feedback expected this quarter ahead of a potential BLA filing. Cohort expansions are enrolling for CTX-8371, while initial patients have been dosed in the Phase 1 study for CTX-10726 and a Phase 2 trial for CTX-471 is set to begin in Q3. Compass Therapeutics operates as a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics.