Welcome to our dedicated page for Mineralys Therapeutics news (Ticker: MLYS), a resource for investors and traders seeking the latest updates and insights on Mineralys Therapeutics stock.
Mineralys Therapeutics, Inc. (MLYS) is a clinical-stage biopharmaceutical company advancing targeted therapies for hypertension, chronic kidney disease, and sleep apnea. This page aggregates official news and press releases, providing investors with essential updates on the company’s progress in developing aldosterone-focused treatments.
Access timely reports on clinical trial milestones, regulatory developments, and strategic partnerships. The curated content includes detailed announcements about lead candidate lorundrostat, a selective aldosterone synthase inhibitor, alongside financial disclosures and market analyses.
Key updates cover:
• Clinical Research: Phase advancements and trial outcomes
• Regulatory Progress: FDA communications and approval pathways
• Corporate Strategy: Collaborations and pipeline expansions
• Financial Updates: Earnings summaries and investment decisions
Bookmark this resource for direct access to primary-source MLYS developments. Visit regularly for objective reporting on innovations in cardiorenal therapeutics.
Mineralys Therapeutics (NASDAQ: MLYS) has published positive results from its pivotal Phase 3 Launch-HTN trial for lorundrostat in the Journal of the American Medical Association (JAMA). The trial, which is the largest study of an aldosterone synthase inhibitor in patients with uncontrolled or treatment-resistant hypertension, enrolled 1,083 participants.
The study demonstrated that lorundrostat 50 mg once daily achieved significant blood pressure reductions: 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) and 19.0 mmHg reduction at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across various patient demographics.
The drug showed a favorable safety profile with mostly mild, transient adverse events. Only 0.6% of patients on lorundrostat experienced elevated potassium levels above 6.0 mmol/L, compared to 0.4% in the placebo group. The trial included patients on two to five existing antihypertensive medications and utilized automated office blood pressure measurements to reflect real-world clinical settings.
- 16.9 mmHg reduction in systolic blood pressure at Week 6 (-9.1 mmHg placebo adjusted) - 19.0 mmHg reduction at Week 12 (-11.7mm placebo adjusted)
The drug showed a favorable safety profile with low incidence of serious adverse events. Only 0.1% of participants experienced treatment-related serious adverse events in the 50mg arm. The trial reflects real-world treatment conditions, with participants maintaining their existing medications (2-5 antihypertensive medications). This marks the second successful pivotal trial for lorundrostat, following the recently published Advance-HTN trial results in The New England Journal of Medicine.
Mineralys Therapeutics (NASDAQ: MLYS) announced that data from its pivotal Phase 3 Launch-HTN trial for lorundrostat will be presented at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025) in Milan. The presentation, scheduled for May 24th, 2025, will showcase results for treating uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).
Lorundrostat is an oral, selective aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2. The drug shows 374-fold selectivity for aldosterone-synthase inhibition and has demonstrated approximately 70% reduction in plasma aldosterone concentration. Previous Phase 2 trials showed meaningful blood pressure reduction, with observed adverse events including increased serum potassium, decreased glomerular filtration rate, and urinary tract infection.
Mineralys Therapeutics (NASDAQ: MLYS) announced positive Q1 2025 results and significant clinical progress for its drug lorundrostat. The company reported successful outcomes in two pivotal trials: Launch-HTN and Advance-HTN, demonstrating statistically significant blood pressure reductions. Launch-HTN showed a 16.9 mmHg reduction in systolic blood pressure at week 6, while Advance-HTN achieved a 15.4 mmHg reduction at 12 weeks.
The company strengthened its financial position with a $201.2 million public equity financing, ending Q1 2025 with $343.0 million in cash and investments. Net loss increased to $42.2 million compared to $31.5 million in Q1 2024. Mineralys appointed Eric Warren as Chief Commercial Officer and expects to hold a pre-NDA meeting with the FDA in Q4 2025.
The company anticipates topline data from its Explore-CKD Phase 2 trial in Q2 2025 and has initiated the Explore-OSA Phase 2 trial in Q1 2025.Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company specializing in treatments for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA), has announced its participation in the Bank of America Securities 2025 Health Care Conference. The event will be held in Las Vegas from May 12-15, 2025.
The company's management will deliver a presentation on Wednesday, May 14, 2025, at 4:35 PM PDT. Investors can access a live webcast of the presentation through the Investor Relations section of Mineralys' website. The presentation recording will remain available for approximately 90 days on the company's website.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company specializing in treatments for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA), has scheduled its Q1 2025 financial results announcement for Monday, May 12, 2025, after market close.
The company will host a conference call at 4:30 p.m. ET to discuss the results. Investors can access the call via domestic (1-800-717-1738) or international (1-646-307-1865) numbers using Conference ID 53214. A live webcast will be available through the Investor Relations section of the company's website.
Mineralys Therapeutics (NASDAQ: MLYS) announced the publication of its pivotal Phase 2 Advance-HTN trial results in the New England Journal of Medicine (NEJM). The study evaluated lorundrostat in patients with uncontrolled or resistant hypertension.
Key findings showed that lorundrostat 50 mg achieved a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001) in 24-hour ambulatory blood pressure at week 12. The drug demonstrated consistent efficacy across different patient groups, including those on varying baseline medications, gender, and racial demographics.
The treatment showed a favorable safety profile with modest changes in potassium, sodium, and eGFR. The results were previously presented at ACC.25 in Chicago. The company plans to present additional data from their pivotal Phase 3 Launch-HTN trial at an upcoming medical conference.
Mineralys Therapeutics (NASDAQ: MLYS) announced detailed results from its Phase 2 Advance-HTN pivotal trial evaluating lorundrostat for uncontrolled and resistant hypertension. The trial demonstrated that lorundrostat 50 mg achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001) in blood pressure at week 12.
The study showed a favorable safety profile with modest changes in potassium, sodium, and eGFR levels. The trial included a diverse patient population, with 40% women and 53% Black participants. Serious adverse events occurred in 6%, 8%, and 2% of patients in the lorundrostat 50 mg, 50-100 mg, and placebo arms respectively.
Lorundrostat functions as a highly selective aldosterone synthase inhibitor, targeting hypertension, chronic kidney disease, and obstructive sleep apnea. The company plans to present additional data from the Phase 3 Launch-HTN trial at an upcoming medical conference.
Mineralys Therapeutics (NASDAQ: MLYS) has announced a key opinion leader (KOL) conference call and webinar scheduled for Tuesday, April 1, 2025, at 8:00 AM ET. The event will feature Dr. Luke Laffin from the Cleveland Clinic, who will present and discuss the latest results from two pivotal clinical trials: Advance-HTN and Launch-HTN.
The presentation will focus on lorundrostat's potential in treating uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). Dr. Laffin will also address the current unmet medical needs in these conditions and how lorundrostat could potentially transform the existing treatment approach.
The event will be accessible via webcast through the Investor Relations section of Mineralys Therapeutics' website under the 'News & Events' page.
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