Mineralys Therapeutics, Inc. Stock Price, News & Analysis

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.

Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other aldosterone-related diseases, has scheduled its fourth quarter and full year 2024 financial results announcement. The results will be released before market open on Wednesday, February 12, 2025.

The company will host a conference call at 8:30 a.m. ET on the same day, accessible via domestic (1-800-717-1738) and international (1-646-307-1865) dial-in numbers. A live webcast will be available through the Investor Relations section of the company's website.

Mineralys Therapeutics (NASDAQ: MLYS) has completed enrollment in its Explore-CKD Phase 2 trial, evaluating lorundrostat for treating hypertension in patients with Stage 2 to 3b CKD and albuminuria. The trial focuses on patients already receiving stable treatment with ACEi or ARB and SGLT2 inhibitors.

The study is designed as a randomized, double-blind, placebo-controlled, two-period, two-sequence crossover trial, testing 25 mg once-daily lorundrostat. The primary endpoint measures change in systolic blood pressure at week four compared to placebo, with an exploratory endpoint examining changes in urine albumin-to-creatinine ratio.

The company expects to announce topline data in Q2 2025. This marks Mineralys's third trial to complete enrollment, alongside Target-HTN, Advance-HTN, and the recently announced Explore-OSA trials.