Keros Suspends Hypertension Trial Arms Amid Safety Concerns, Impact on Stock and Upcoming Takeda Deal
Keros Therapeutics has decided to halt dosing in two out of three treatment arms of its Phase II TROPOS trial for the pulmonary arterial hypertension drug, cibotercept, following unexpected adverse events. Reports indicated cases of pericardial effusion, a condition where fluid accumulates around the heart, in the 3-mg/kg and 4.5-mg/kg dosage groups. As a result, these higher-dose arms have been suspended, though the 1.5-mg/kg arm will continue under the guidance of an independent data monitoring committee[1][2]. Keros has reported these safety concerns to the FDA and plans to reveal top-line data from all cohorts by Q2 2025[2].
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What measures is Keros Therapeutics taking to address the safety concerns related to cibotercept in their ongoing trials?
How might the suspension of higher dosage arms in the TROPOS study affect the future development of cibotercept for pulmonary arterial hypertension?
What potential impacts could the recent stock price decline have on Keros Therapeutics' financial health and strategic initiatives?
How is Keros planning to leverage its partnership with Takeda to mitigate the financial repercussions from the suspension of the TROPOS trial arms?
What are the projected timelines and key milestones for Keros in bringing elritercept to market after securing global rights with Takeda?