Mineralys Therapeutics, Inc. (MLYS), reported positive post hoc data from Phase 3 Launch-HTN and Phase 2b Advance-HTN trials on the effect of Lorundrostat on heart failure risk biomarkers.
Company Profile:
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing therapies for hypertension and related cardio-renal diseases driven by dysregulated aldosterone.
Hypertension:
Hypertension is a condition characterized by elevated blood pressure (BP), which increases the risk of heart disease and stroke. Globally, approximately 1 in 3 adults is affected by this condition. In the United States, about 50% of adults have hypertension, and over 10 million individuals experience treatment-resistant hypertension. (Source: Mineralys Therapeutics-Pipeline)
Lorundrostat:
Lorundrostat is an orally administered compound in evaluation for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). As an aldosterone synthase inhibitor, it targets the CYP11B2 enzyme to lower aldosterone levels.
Lorundrostat is currently under review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.
Launch-HTN & Advance-HTN Clinical Trial:
Launch-HTN is a Phase 3 randomized, double-blind, and placebo-controlled clinical trial that enrolled adults whose blood pressure remained uncontrolled despite treatment with two or five antihypertensive medications. The primary endpoint was the change from baseline in systolic blood pressure at six weeks compared with placebo.
Advance-HTN is a Phase 2 randomized, double-blind, placebo-controlled trial that assessed the efficacy and safety of lorundrostat as add-on therapy to standardized treatment with two or three antihypertensive medications in patients with a history of antihypertensive treatment who experienced uncontrolled or resistant hypertension. The primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week 12 compared with baseline.
Key Highlights:
The company noted that the post hoc analysis was based on 1,004 participants enrolled in the pivotal Phase 3 Launch-HTN and Phase 2b Advance-HTN trials. The results classified the systemic pharmacodynamic (PD) effects of lorundrostat by profiling circulating protein biomarkers at baseline and after 12 weeks.
-The result demonstrated that lorundrostat increased renin levels and decreased angiotensinogen, indicating target engagement with the renin-angiotensin-aldosterone system (RAAS).
-Lorundrostat significantly reduced six of eleven candidate biomarkers, including NT-proBNP associated with incident heart failure risk. These findings are consistent with the hypothesis that RAAS inhibition may modulate pathways involved in HF risk, the firm noted.
-Mineralys noted that lorundrostat treatment was associated with coordinated changes in key biomarkers: reductions in markers of scarring and heart failure risk and increases in markers of hemostasis and protease inhibitor activity.
Conclusion:
Mineralys reports that these findings are consistent with lorundrostat's proposed mechanism of action and suggests that lorundrostat may influence biological pathways associated with heart failure risk, supporting further clinical evaluation in this setting.
Mineralys shares closed Friday at $23.62, down 1.34%. In the overnight market, shares are trading at $25.00, up 5.84%.
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