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) 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.
Mineralys Therapeutics (Nasdaq: MLYS) has successfully closed the sale of an additional 1,944,444 shares of common stock at $13.50 per share, following the full exercise of the underwriters' option in connection with its recent public offering. The total gross proceeds from the offering reached approximately $201.2 million before deducting underwriting discounts and other expenses.
The offering was managed by multiple financial institutions, including BofA Securities, Evercore ISI, Goldman Sachs & Co. , Stifel, and Wells Fargo Securities as joint book-running managers. The company plans to use the net proceeds to fund the clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes.
Mineralys Therapeutics (Nasdaq: MLYS) has announced that data from their Phase 2 Advance-HTN trial of lorundrostat will be presented as a late-breaking presentation at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in Chicago, March 29-31, 2025.
The trial evaluates the efficacy and safety of lorundrostat for treating uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). Lorundrostat is being developed as part of the company's focus on medicines targeting hypertension, chronic kidney disease (CKD), obstructive sleep apnea and other diseases driven by dysregulated aldosterone.
Mineralys Therapeutics (Nasdaq: MLYS) has announced the pricing of an underwritten public offering of 12,962,962 shares of common stock at $13.50 per share, expecting to raise gross proceeds of approximately $175.0 million.
The company has granted underwriters a 30-day option to purchase up to an additional 1,944,444 shares. The offering is expected to close around March 13, 2025. BofA Securities, Evercore ISI, Goldman Sachs & Co. , Stifel, and Wells Fargo Securities are acting as joint book-running managers.
The proceeds will be used to fund clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as working capital and general corporate purposes.
Mineralys Therapeutics (MLYS) has announced a proposed public offering of $250.0 million of common stock shares. The company plans to grant underwriters a 30-day option to purchase up to an additional $37.5 million of shares at the public offering price, less underwriting discounts and commissions.
The clinical-stage biopharmaceutical company, focused on developing medicines for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA), will use the net proceeds to fund clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as working capital and general corporate purposes.
The offering is being managed by joint book-runners BofA Securities, Evercore ISI, Goldman Sachs & Co. , Stifel, and Wells Fargo Securities, with LifeSci Capital as lead manager and H.C. Wainwright & Co. as co-manager.
Mineralys Therapeutics (NASDAQ: MLYS) announced positive topline results from two pivotal trials evaluating lorundrostat for uncontrolled or resistant hypertension treatment. The Launch-HTN Phase 3 trial met its primary endpoint, with the 50mg dose achieving a 9.1 mmHg placebo-adjusted reduction in systolic blood pressure at week 6 (p<0.0001), and an 11.7 mmHg reduction at week 12.
The Advance-HTN Phase 2 trial also succeeded, showing a significant 7.9 mmHg placebo-adjusted reduction in 24-hour blood pressure monitoring at week 12. Both trials demonstrated favorable safety profiles, with low rates of serious adverse events. Hyperkalemia incidence was 1.1-1.5% in Launch-HTN and 5.3-7.4% in Advance-HTN.
This development targets approximately 15-20 million patients with uncontrolled hypertension in the United States. Full results from Advance-HTN will be presented at the American College of Cardiology Scientific Sessions on March 29, 2025.
Mineralys Therapeutics (NASDAQ: MLYS) has scheduled a conference call and webinar for March 10, 2025, at 8:00 AM ET to announce topline results from two pivotal trials: Launch-HTN and Advance-HTN.
The trials evaluated lorundrostat, a highly selective aldosterone inhibitor, for treating uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The Launch-HTN trial tested lorundrostat as an add-on therapy to existing prescribed background treatment of 2-5 antihypertensive medications, while Advance-HTN evaluated it as an add-on to a standardized background treatment of 2-3 anti-hypertensive medications.
Mineralys Therapeutics (NASDAQ: MLYS) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its clinical development programs. The company anticipates topline data from two pivotal trials: Advance-HTN in March 2025 and Launch-HTN in mid-first half of 2025, both evaluating lorundrostat for uncontrolled or resistant hypertension.
Financial highlights include cash position of $198.2 million as of December 31, 2024, expected to fund operations through Q1 2026. R&D expenses increased to $168.6 million for 2024, up from $70.4 million in 2023. The company reported a net loss of $177.8 million for 2024, compared to $71.9 million in 2023.
The company completed enrollment in the Explore-CKD Phase 2 trial with data expected in Q2 2025 and plans to initiate a Phase 2 trial for obstructive sleep apnea and hypertension in Q1 2025.
