Business
Mineralys Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
– Anticipate topline data from pivotal Advance-HTN trial in March 2025 and pivotal Phase 3 Launch-HTN trial in mid first half of 2025 – – Completed enrollment
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Anticipate topline data from pivotal Advance-HTN trial in March 2025 and pivotal Phase 3 Launch-HTN trial in mid first half of 2025 – – Completed enrollment in Explore-CKD Phase 2 trial and anticipate delivering topline data in Q2 2025 – – Initiating Phase 2 trial to evaluate lorundrostat for the treatment of patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension – – Conference call today at 8:30 a.m. ET – RADNOR, Pa., Feb. 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 fourth quarter and full year ending December 31, 2024, and provided a corporate update. “This past year was important for the development of lorundrostat, and the entire Mineralys team contributed to the execution of our clinical strategy. Over the course of the next several months we anticipate delivering topline data from our pivotal program to treat patients with uncontrolled or resistant hypertension,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Our clinical development program is focused on high-risk patients with poorly controlled hypertension who may benefit from this novel treatment. Based on the extensive medical data showing the impact dysregulated aldosterone can have on the human body, we believe that targeting aldosterone with lorundrostat can have a positive impact on millions of patients’ lives.” Recent Clinical Highlights and Upcoming Milestones Pivotal Advance-HTN Trial – Anticipate reporting topline data in March 2025. The trial is evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to a standardized background treatment. The trial’s primary endpoint is the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for each active cohort versus placebo.Pivotal Launch-HTN Phase 3 Trial – Anticipate reporting topline data in mid first half of 2025. This is the second ongoing pivotal trial of lorundrostat for the treatment of subjects with uHTN or rHTN as add-on therapy, who f...