Shares of ABL Bio fell sharply early Tuesday after news that its subsidiary’s bile duct cancer drug candidate “tovecimig” failed to meet the overall survival (OS) endpoint in a Phase 2/3 trial.
According to the Korea Exchange, ABL Bio was trading at 137,400 won as of 10:20 a.m., down 35,300 won, or 20.44%, from the previous session.
The move followed an announcement by ABL Bio’s U.S. unit, Compass Therapeutics, which said on April 27 local time that it released trial results comparing a combination of tovecimig and the chemotherapy drug paclitaxel with monotherapy.
Compass said the treatment group’s OS did not achieve statistical significance. The company said the outcome was affected because more than half of patients in the control group, 54%, switched to the study drug during treatment.
Kim Min-jung, an analyst at DS Investment &u0026 Securities, wrote in a report Tuesday that when objective response rate (ORR) data were previously disclosed, the U.S. Food and Drug Administration asked Compass Therapeutics to provide final median overall survival (mOS) data from the Phase 2/3 trial. “Because the requested mOS data failed to achieve statistical superiority, it will not be easy to obtain U.S. FDA approval,” Kim said.
Kim added, however, that the impact on ABL Bio’s corporate value would be “very limited,” citing the small number of patients in the bile duct cancer market and a short median progression-free survival (mPFS) of about 4.7 months, which limits treatment duration and commercial potential.
Meritz Securities analyst Kim Jun-young said that if the drug does not receive a review designation, the company’s projected possibility of a Prescription Drug User Fee Act (PDUFA) decision in the second half of 2027 would diminish, with a potential delay to the first half of 2028. He also said there is a possibility regulators could require additional confirmatory trials.
Kim said tovecimig’s new-drug value is estimated at 178.9 billion won, limiting the overall impact, and added that key investment points remain intact, including the scalability of the BBB shuttle-based Grabody B platform and the potential for technology transfer of ABL111, which he said is producing positive clinical results. He said investors should watch for additional technology-transfer opportunities and momentum from ABL111 trials.
* This article has been translated by AI.
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