Mineralys Therapeutics Presents New Data from the Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Hypertension and Chronic Kidney Disease at European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)

MLYSNASDAQMineralys Therapeutics, Inc. Common Stock·May 30, 2026, 03:15 PM·GlobeNewswire Inc.

Impact

(Medium)

Sentiment

(Positive)

Stonvex AI Summary

Mineralys Therapeutics presented Phase 3 data for lorundrostat showing a 9.6 mmHg placebo-adjusted systolic blood pressure reduction in hypertensive patients with chronic kidney disease and a 52.2% reduction in urinary albumin-to-creatinine ratio in those with baseline albuminuria. The drug demonstrated a favorable safety profile and is under FDA review with a PDUFA decision expected by December 22, 2026.

Positive

■Statistically significant blood pressure reductions (9.6 mmHg) and substantial albuminuria reduction (52.2%) demonstrate clinical efficacy in the target patient population
■Favorable safety profile supports potential for regulatory approval and differentiation in the hypertension and CKD treatment market
■FDA PDUFA target date of December 22, 2026 provides a near-term catalyst for potential approval and commercialization

Negative

■Data presented at a medical conference rather than published in peer-reviewed journals, limiting independent verification
■Regulatory approval is not guaranteed; FDA may request additional data or raise safety concerns during review
■Competitive market with existing hypertension treatments may limit peak sales potential and market adoption

Original excerpt

Mineralys Therapeutics presented post hoc analysis data from its Phase 3 Launch-HTN trial showing that lorundrostat, an aldosterone synthase inhibitor, achieved statistically significant blood pressure reductions in patients with chronic kidney disease (CKD) and hypertension. The drug demonstrated a 9.6 mmHg placebo-adjusted systolic blood pressure reduction in CKD patients and a 52.2% reduction in urinary albumin-to-creatinine ratio in those with baseline albuminuria, with a favorable safety profile. The drug is currently under FDA review with a PDUFA target date of December 22, 2026.

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