– In the largest long-term hypertension trial of an aldosterone synthase inhibitor to date, lorundrostat demonstrated sustained reduction in automated office systolic blood pressure (AOSBP) of 17.8 mmHg at Week 48 from Launch-HTN baseline – – 56% of participants reached AOSBP below 130 mmHg at Week 48 – – Long-term treatment with lorundrostat was well tolerated, with no new clinically relevant safety findings beyond Launch-HTN – – U.S. FDA review of lorundrostat is underway, with a PDUFA target date of December 22, 2026 – RADNOR, Pa., Nov. 08, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone, today announced long-term results from the Transform-HTN open-label extension trial of lorundrostat in participants with uncontrolled or resistant hypertension, demonstrating sustained reductions in AOSBP following lorundrostat treatment in Launch-HTN. The results were presented in a late-breaking oral session at the American Heart Association (AHA) Scientific Sessions 2026 in Chicago, IL, on Sunday, November 8, 2026, at 3:35 p.m. CT. “For patients whose blood pressure remains uncontrolled despite multiple medications, particularly those in high-risk populations disproportionately affected by hypertension, the question in practice is whether a treatment can deliver both rapid and sustained blood pressure control,” said Manish Saxena, MBBS, Clinical Co-Director of Queen Mary University of London’s William Harvey Clinical Research Centre and Hypertension Specialist at Barts Health NHS Trust. “In Transform-HTN, lorundrostat demonstrated sustained blood pressure reductions for nearly a year, with more than half of participants achieving the guideline-recommended systolic blood pressure target of less than 130 mmHg, an important goal for reducing long-term cardiovascular and kidney risks.” Efficacy Results from Transform-HTN In this open-label extension trial, lorundrostat demonstrated a clinically meaningful 17.8 mmHg absolute reduction in AOSBP from the Launch-HTN baseline through 48 weeks (p