Compass Therapeutics Inc.FDA recommended a new survival trial before a tovecimig BLA submission, delaying the regulatory path for Compass Therapeutics.

Compass Therapeutics said the FDA recommended it run a trial demonstrating a survival benefit before submitting a BLA for tovecimig in biliary tract cancer, while the company stated it does not believe a new trial is warranted prior to submitting a BLA. In the Phase 2/3 COMPANION-002 study, tovecimig plus paclitaxel showed a statistically significant improvement in objective response rate of 18.0% versus 5.3% with paclitaxel alone, and median progression-free survival of 4.7 versus 2.6 months with a hazard ratio of 0.44, a 56% reduction in the risk of disease progression. Overall survival analyses were confounded by high crossover and prolonged survival in crossover patients randomized to the control arm and then treated with tovecimig, and therefore did not meet statistical significance. Compass Therapeutics shares were down 29.40% at $1.28 at the time of publication, trading at a new 52-week low.
Compass Therapeutics Inc.FDA recommended a new survival trial before a tovecimig BLA submission, delaying the regulatory path for Compass Therapeutics.
Compass Inc