Compass Therapeutics just got a call no biotech wants. The FDA told Compass it will not review tovecimig for approval until a new trial proves the drug helps patients with advanced biliary tract cancer live longer. ABL Bio, which developed the drug, now faces a major delay in its first shot at royalty revenue.
In its official update, Compass Therapeutics stated that the FDA specifically requested a new trial to demonstrate overall survival benefit, rather than accepting additional analysis of existing data.
The FDA did not budge. In a pre-submission meeting, regulators told Compass to run a new trial focused on overall survival before filing for approval. Compass CEO Thomas Schuetz called it a setback. He said, “We respect the FDA’s opinion,” but argued the data still matter for patients with advanced biliary tract cancer. The market disagreed. Compass shares crashed over 30% intraday after the news. A BioWorld market review reported the stock also dropped 27% in other sessions after the announcement.
ABL Bio has more trouble brewing at home. South Korean financial regulators are investigating claims that CEO Lee Sang-hoon’s family and some executives’ spouses traded company shares around the time of technology transfer deals with GlaxoSmithKline and Eli Lilly. The trades allegedly used information that was not public. Authorities are now digging into when leaks happened during these high-stakes talks, which pulled in teams from R&D and legal.
The COMPANION-002 trial, which Compass positioned as the pivotal study for tovecimig in biliary tract cancer, improved objective response and progression-free survival but failed to show a statistically significant overall survival benefit—prompting the FDA to request new evidence before considering a BLA submission.
ABL Bio is not out of options. Its pipeline is still moving. Zivastomig (ABL111), a bispecific antibody for gastric cancer co-developed with Novabridge Biosciences, just got FDA Fast Track status. A global Phase 3 trial is set for later this year. Another drug, lazistomig (ABL503), is in Phase 1 trials in the U.S. and South Korea. New studies are planned to test it in more cancer types and combinations. These programs use ABL Bio’s own bispecific antibody platform. Now, they face pressure to deliver the results and revenue that tovecimig could not.
ABL Bio’s struggle is not unique. Oncology biotech is a tough field. The FDA’s demand for hard survival data can derail even promising drugs. As a TradingView regulatory update explains, survival data is now a make-or-break hurdle for companies chasing faster approvals. For ABL Bio, the path is clear. No survival data, no approval. No royalties. The company’s future now depends on what its next trials can prove.
