RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) said this week it is approaching a pivotal stretch of clinical and regulatory milestones for lorundrostat, its lead drug candidate for difficult-to-treat hypertension and related conditions, as it awaits additional data and progress on a pending federal review.
The biotechnology company said it remains on track to report topline results in the first quarter of 2026 from its Phase 2 Explore-OSA trial, which is evaluating lorundrostat’s impact on both blood pressure and symptoms of obstructive sleep apnea in patients with hypertension and moderate to severe OSA. Enrollment for the study was completed in the third quarter of 2025.
Mineralys also confirmed that it filed a New Drug Application for lorundrostat with the U.S. Food and Drug Administration in late 2025, following a clinical program that included three positive trials completed last year. The company said those studies demonstrated sustained 24-hour blood pressure control and a favorable safety profile across a range of patient populations with uncontrolled or resistant hypertension.
Management said confidence in lorundrostat’s potential has continued to build as data have accumulated. The company expects upcoming Explore-OSA results to further support its strategy of positioning the drug for patients with hypertension and common comorbid conditions.
Beyond the NDA submission, Mineralys highlighted continued progress across its broader clinical portfolio. Its Transform-HTN open-label extension trial is ongoing and is designed to provide additional long-term safety and efficacy data while allowing participants continued access to lorundrostat. In parallel, the Phase 2 Explore-CKD trial met its primary endpoint, showing statistically meaningful reductions in systolic blood pressure and proteinuria in patients with hypertension and chronic kidney disease.
The company has also completed two pivotal trials supporting its regulatory filing. The global Launch-HTN Phase 3 trial met its primary endpoint in patients with uncontrolled or resistant hypertension who failed to achieve adequate blood pressure control on existing therapies. The Advance-HTN trial similarly met its primary endpoints in a high-risk population treated on top of optimized, guideline-directed background medications.
Lorundrostat is an oral, highly selective aldosterone synthase inhibitor designed to reduce aldosterone production by targeting the CYP11B2 enzyme. Mineralys said the drug demonstrated strong selectivity in clinical testing, along with clinically meaningful reductions in plasma aldosterone levels and durable blood pressure lowering.
Separately, the company said members of its management team will participate in the 15th LifeSci Partners Corporate Access event, scheduled for January 12 through January 14, 2026, in San Francisco.
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