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Mineralys Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety and tolerability profile – – Anticipate Explore-CKD Phase 2 trial to deliver topline data in Q2 2025 – – Initiated Explore-OSA Phase 2 Trial in Q1 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. “We are pleased to have recently announced positive topline results from our pivotal trials, Launch-HTN and Advance-HTN, that evaluated lorundrostat’s efficacy and safety as a potential treatment for patients with uncontrolled or resistant hypertension. The Advance-HTN late-breaking presentation at the American College of Cardiology meeting and the recent publication in the New England Journal of Medicine underscore the strength of our clinical data and the potentially transformative nature of lorundrostat. With the success of our two pivotal trials, we are working toward submitting our new drug application with a pre-NDA meeting with the FDA anticipated in the fourth quarter of 2025,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We are excited to announce the appointment of Eric Warren as our Chief Commercial Officer. Eric’s proven leadership skills, extensive cardiovascular experience and track record of success, will be invaluable to Mineralys as we solidify our commercial and partnering strategy.” Recent Clinical Highlights and Upcoming Milestones Pivotal Launch-HTN Phase 3 Trial – The trial met its primary endpoint in evaluating the efficacy and safety of lorundrostat for the treatment of subjects with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as add-on therapy, who fail to achieve blood pressure control on their existing medications. The trial reported that the lorundrostat 50 mg dose achieved a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value The Launch-HTN trial has...