Keros Suspends Hypertension Trial Arms After Safety Concerns, Stock Drops Over 70%

Keros Therapeutics has announced the suspension of two arms in its Phase II TROPOS trial for the hypertension drug cibotercept due to unexpected safety concerns. Specifically, there were reports of pericardial effusion, an abnormal fluid accumulation around the heart, in the trial participants receiving the higher 3-mg/kg and 4.5-mg/kg doses, which prompted the suspension of these dosing arms. The 1.5-mg/kg dose cohort will continue as planned under the guidance of an independent data monitoring committee[1][2]. Patient safety remains the top priority, and Keros is working closely with the FDA and other regulatory bodies to address these concerns, aiming to report top-line data by the second quarter of 2025[2].
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Explore Further
What specific safety measures is Keros implementing to monitor the 1.5-mg/kg dosing cohort in the TROPOS trial?
How does Keros plan to address and potentially mitigate the financial impact of the 70% stock drop amid the trial suspension?
What are the possible next steps for Keros if the continued 1.5-mg/kg cohort reveals additional safety concerns?
How might the safety issues with cibotercept influence Keros's strategic collaboration with Takeda on elritercept development?
What implications does the suspension of higher doses have for the future regulatory approval process for cibotercept?