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) has successfully closed its upsized public offering of common stock, raising $287.5 million in gross proceeds. The offering included 11,274,509 shares at $25.50 per share, with the underwriters exercising their full option to purchase an additional 1,470,588 shares.
The biopharmaceutical company, which focuses on developing treatments for hypertension and related conditions like chronic kidney disease and obstructive sleep apnea, plans to use the proceeds to fund the clinical development of its drug candidate lorundrostat, including R&D, manufacturing, and pre-commercialization activities. The offering was managed by several prominent investment banks, including BofA Securities, Evercore ISI, Goldman Sachs, Stifel, and Wells Fargo Securities.
Mineralys Therapeutics (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on hypertension treatments, has announced the pricing of an upsized public offering of 9,803,921 shares of common stock at $25.50 per share.
The offering is expected to generate gross proceeds of approximately $250.0 million. The company has also granted underwriters a 30-day option to purchase up to an additional 1,470,588 shares. The proceeds will fund the clinical development of lorundrostat, including R&D, manufacturing, and pre-commercialization activities.
The offering, expected to close around September 4, 2025, is being managed by multiple investment banks including BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities as joint book-running managers.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company, has announced a proposed public offering of $175.0 million of common stock shares. The company plans to grant underwriters a 30-day option to purchase up to an additional $26.25 million of shares.
The offering will be managed by several prominent investment banks, including BofA Securities, Evercore ISI, Goldman Sachs, Stifel, and Wells Fargo Securities as joint book-running managers. The proceeds will be used to fund the clinical development of lorundrostat, including R&D, manufacturing, and pre-commercialization activities, as well as working capital and general corporate purposes.
Mineralys Therapeutics (Nasdaq: MLYS) reported Q2 2025 financial results and significant clinical progress for lorundrostat, their hypertension treatment candidate. The company achieved positive results from three clinical trials, including the pivotal Launch-HTN and Advance-HTN trials, with results published in JAMA and NEJM respectively.
The Explore-CKD Phase 2 trial demonstrated statistical significance with lorundrostat 25mg achieving a 7.5 mmHg placebo-adjusted reduction in systolic BP and a 25.6% placebo-adjusted reduction in UACR. The company has scheduled a pre-NDA meeting with the FDA for Q4 2025.
Financially, Mineralys reported cash and investments of $324.9M as of June 30, 2025, with runway into 2027. Q2 2025 resulted in a net loss of $43.3M, compared to $41.0M in Q2 2024.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company specializing in hypertension treatments, will release its Q2 2025 financial results on Tuesday, August 12, 2025, after market close. The company will host a conference call at 4:30 p.m. ET the same day.
The company, which focuses on developing medicines for hypertension, hypertensive nephropathy, and obstructive sleep apnea (OSA), will make the earnings call accessible via phone and webcast. Investors can join using domestic (1-877-704-4453) or international (1-201-389-0920) dial-in numbers with conference ID 13754684.
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.FAQ
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