AstraZeneca Plc (NASDAQ:AZN) on Monday released topline data from the BaxHTN Phase 3 trial of baxdrostat in patients with uncontrolled or treatment-resistant hypertension.
The trial included patients who were treated with two different antihypertensive medications and patients with resistant hypertension being treated with three or more different antihypertensive medications, one of which is a diuretic.
The trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks.
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The trial also met all secondary endpoints. Patients with uncontrolled or treatment-resistant hypertension received baxdrostat or placebo on top of standard of care. Baxdrostat was generally well tolerated and had a favourable safety profile.
There are 1.3 billion people worldwide living with hypertension. When uncontrolled, hypertension can lead to a higher risk of heart attack, stroke, heart failure, and kidney disease. In the U.S., approximately 50% of hypertensive patients who are on multiple treatments do not have their blood pressure under control.
The data will be shared with regulatory authorities worldwide and presented in a late‑breaking Hot Line session at the European Society of Cardiology (ESC) Congress in August 2025.
AstraZeneca acquired baxdrostat by purchasing CinCor Pharma, Inc. in February 2023. A contingent value right of $10 per share in cash ($0.5 billion) is payable to former CinCor shareholders upon submitting a new drug application in the U.S. or Europe.
In related news, Merck & Co., Inc. (NYSE:MRK) recently received priority review from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Winrevair (sotatercept-csrk).
This application aims to update the U.S. product label based on compelling data from the Phase 3 ZENITH trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.
In 2024, Winrevair was approved for adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
Price Action: AZN stock is trading higher by 0.60% to $71.57 during the premarket session at last check Monday.
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