By Dean Seal


Compass Therapeutics said regulators have granted fast-track designation to its CTX-009 antibody in combination with paclitaxel for the treatment of biliary tract cancer.

The clinical-stage biopharmaceutical company said Thursday that the special status from the U.S. Food and Drug Administration will fast-track the development of the combination for patients with metastatic or locally advanced biliary tract cancer that have been previously treated.

The FDA's fast-track designation facilitates development and expedites the review of drugs that treat serious or life-threatening conditions and fill unmet medical needs.

Thomas Schuetz, Compass' president of research and development as well as vice chair of its board, said the company is currently evaluating the combination after observing nine partial responses in 24 patients treated in a Phase 2 study.

Compass is on track to complete enrollment in the current study midway through the year and report top line data by year's end.


Write to Dean Seal at dean.seal@wsj.com


(END) Dow Jones Newswires

04-25-24 0836ET