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. (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Company news frequently centers on clinical trial milestones, regulatory interactions and scientific recognition related to hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other conditions driven by dysregulated aldosterone.
News updates from Mineralys describe progress across a broad clinical program. These include topline and subgroup results from the pivotal Launch-HTN Phase 3 trial in uncontrolled or treatment-resistant hypertension, data from the Advance-HTN trial, and long-term follow-up in the Transform-HTN open-label extension. Additional coverage highlights Phase 2 studies such as Explore-CKD, which evaluated lorundrostat in participants with hypertension, CKD and albuminuria, and Explore-OSA, a trial in overweight or obese adults with moderate-to-severe OSA and hypertension.
Investors and observers can also find announcements about regulatory steps, such as plans for and filing of a New Drug Application (NDA) for lorundrostat with the U.S. Food and Drug Administration, as well as public equity offerings and other financing activities disclosed in SEC filings and press releases. Mineralys regularly reports on participation in major medical and scientific meetings, where data from Launch-HTN and Explore-CKD have been featured in sessions and roundups by organizations such as the American Society of Nephrology and the Journal of the American Medical Association.
This news feed aggregates these developments so readers can follow Mineralys Therapeutics’ clinical, regulatory, financial and corporate communications over time, with a particular focus on the evolving evidence base for lorundrostat in hypertension and related comorbidities.
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.
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.
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