Lorundrostat - (Launch-HTN)

June 14, 2026: Mineralys Therapeutics, Inc. (NASDAQ: MLYS) presented a late-breaking poster at ENDO 2026 (Chicago) reporting a post hoc proteomic pharmacodynamic analysis of lorundrostat in participants with uncontrolled hypertension from the Phase 3 Launch-HTN and Phase 2b Advance-HTN trials (n=1,004; biomarkers assessed at baseline and after 12 weeks). Lorundrostat showed RAAS target engagement (increased renin; decreased angiotensinogen) and was associated with significant reductions in 6 of 11 recently published candidate causal risk biomarkers for incident heart failure, including NT-proBNP. Versus placebo, coordinated biomarker shifts included reductions in markers of fibrosis/scarring and heart failure risk and increases in markers of hemostasis and protease inhibitor activity, which the company says supports biological plausibility for evaluating lorundrostat in heart failure.

Regulatory catalyst: Lorundrostat is under FDA review, with a PDUFA target date of December 22, 2026.

Trial context: Launch-HTN primary endpoint is change in systolic BP at 6 weeks vs placebo; Advance-HTN primary endpoint is change in 24-hour ambulatory systolic BP at week 12 vs placebo.