Mineralys Therapeutics Inc. (MLYS) has several upcoming milestone events this year related to its lead candidate, Lorundrostat, a selective aldosterone synthase inhibitor.
"As we reflect on the data generated with lorundrostat to date, we are more confident than ever of the drug candidate's best-in-class profile, based on the clinically meaningful blood pressure reduction, the demonstrated 24-hour control, its benefit across the spectrum of difficult-to-treat patients, and its safety and tolerability profile," said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.
The company will present at the 15th LifeSci Partners Corporate Access event in San Francisco from January 12-14, 2026, where management is expected to highlight recent progress and upcoming milestones.
Lorundrostat Clinical Program:
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2. It has demonstrated 374-fold selectivity for aldosterone synthase versus cortisol synthase in vitro, with a half-life of 10-13 hours and reductions of 40-70% in plasma aldosterone concentration in hypertensive participants.
The drug has now completed four successful clinical trials, including two pivotal registrational studies- Launch-HTN Phase 3 and Advance-HTN Phase 2- both of which met primary endpoints and reinforced Lorundrostat's favorable safety profile.
Upcoming Milestones:
• Topline results expected in Q1 2026 for Phase 2 Explore-OSA trial evaluating Lorundrostat in patients with hypertension and moderate to severe obstructive sleep apnea.
• The company has filed an NDA for Lorundrostat in uncontrolled and resistant hypertension, with FDA review anticipated in 2026.
• Mineralys is conducting the Transform-HTN open-label extension study to generate long-term safety and efficacy data in patients with uncontrolled and resistant hypertension.
The company ended September 30, 2025, with a cash, cash equivalents, and investments of $593.6 million, expected to fund clinical trials, regulatory activities, and corporate operations into 2028.
MLYS has traded in the range of $8.24 and $47.65 over the past year. The stock closed yesterday's trading at $35.71, up 0.41%.
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