Keros shares plunge as safety doubts prompt dosing pause in blood pressure drug trial
Updates shares in paragraph 1, adds market cap in paragraph 8
Dec 12 (Reuters) -Keros Therapeutics KROS.O said on Thursday it has paused giving patients higher doses of its high blood pressure treatment in a mid-stage study after reports of a safety issue, sending its shares plunging 72% in premarket trading.
The drug is being tested in patients with pulmonary arterial hypertension and its dosing was halted after a safety review observed fluid buildup around the heart in patients.
"We are working diligently to gain a better understanding of these unanticipated findings," CEO Jasbir Seehra said.
The trial was testing the experimental drug, cibotercept, in combination with a background therapy in patients with the condition that refers to high blood pressure that affects the arteries in the lungs.
Keros said it has notified investigators and regulators, including the U.S. Food and Drug Administration, about its decision and will work with them to "address this as quickly as possible".
It was pausing administration of the 3.0 milligram (mg) and 4.5 mg doses of the drug, but would continue testing the 1.5 mg dose of the drug after completing a risk and benefit assessment of the data by a independent data monitoring committee.
The company intends to continue safety and efficacy data collection for all treatment groups in the trial and expects to present data in the trial during the second quarter of 2025.
Keros had cash and cash equivalents of $530.7 million as of Sept. 30. It has a market capitalization of $2.78 billion as of last closing price.
Reporting by Sneha S K; Editing by Abinaya Vijayaraghavan and Arun Koyyur
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