Mineralys Therapeutics, Inc. Stock Price, News & Analysis

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.

Mineralys Therapeutics (MLYS) announced positive Phase 2 Explore-CKD trial results for lorundrostat in treating hypertension with CKD. The trial met its primary endpoint with lorundrostat 25mg daily achieving a 9.3 mmHg reduction in systolic blood pressure and a 7.5 mmHg placebo-adjusted reduction (p=0.0024). The drug showed a 31% reduction in urine albumin-to-creatinine ratio (p<0.0001) and demonstrated a favorable safety profile. This marks the fourth successful trial for lorundrostat, adding to previous positive results from Launch-HTN and Advance-HTN pivotal trials. The study involved 59 patients with CKD and albuminuria, showing significant improvements in both blood pressure and kidney-related metrics. The safety profile was notable with only 3% of patients experiencing treatment-emergent adverse events leading to discontinuation during the lorundrostat period.

Mineralys Therapeutics (NASDAQ: MLYS) announced pivotal results from its Phase 3 Launch-HTN trial for lorundrostat in treating uncontrolled or resistant hypertension. The trial, involving over 1,000 participants, demonstrated significant efficacy with lorundrostat 50mg once daily:

- 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.