Compass Therapeutics to file BLA for tovecimig despite FDA call for new trial

Compass Therapeutics announced it will continue pursuing a biologics license application (BLA) for its bispecific antibody tovecimig aimed at advanced biliary tract cancer, even after the FDA suggested a new clinical trial.

The FDA recommendation calls for a study that demonstrates a survival benefit before the drug can be reviewed, which could add roughly three years to the development timeline. Compass noted the agency’s advice is not mandatory for filing.

The Phase 2/3 COMPANION-002 trial showed a confusing result: while the drug met its primary endpoint of improving progression‑free survival, the overall data were described as “confounding.” The company’s share price fell about 30% after the news, extending a year‑to‑date decline of roughly 75%.