Compass Therapeutics Says FDA Recommends New Tovecimig Trial in Biliary Tract Cancer; Shares Fall

09:22 AM EDT, 09/22/2026 (MT Newswires) -- Compass Therapeutics (CMPX) shares fell more than 38% pre-bell Tuesday after the company said the US Food and Drug Administration recommended a new trial showing survival benefit before submitting a biologics license application for tovecimig in patients with previously treated, advanced biliary tract cancer. The company said it does not believe a new trial is warranted and that it remains confident in the experimental drug based on the results from a phase 2/3 study. Data from the phase 2/3 study showed statistically significant improvements in objective response rate and progression-free survival, with tovecimig combined with paclitaxel delivering an 18% ORR, compared with 5.3% with paclitaxel alone, and a median PFS of 4.7 months, versus 2.6 months, the company said. Overall survival analyses, however, did not meet statistical significance, the company said. Compass said it will engage with the FDA to determine the pathway for a biologics license application for tovecimig.