Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing medicines targeting hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone [3] - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions affected by dysregulated aldosterone [3] Financial Results Announcement - Mineralys Therapeutics will report its financial results for the first quarter ended March 31, 2025, after the financial markets close on May 12, 2025 [1] - A live conference call will take place on May 12 at 4:30 p.m. ET, with details provided for both domestic and international participants [2]

Core Insights - Mineralys Therapeutics has published significant results from the Phase 2 Advance-HTN trial, demonstrating the efficacy of lorundrostat in reducing blood pressure in patients with uncontrolled or resistant hypertension [1][3] - The publication in the New England Journal of Medicine highlights the potential of lorundrostat as a transformative treatment targeting dysregulated aldosterone, a key factor in hypertension [3][10] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, driven by dysregulated aldosterone [1][10] - The company's lead product, lorundrostat, is a highly selective aldosterone synthase inhibitor designed to lower aldosterone levels and improve blood pressure control [7][10] Clinical Trial Results - The Advance-HTN trial showed that lorundrostat 50 mg resulted in a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in 24-hour ambulatory blood pressure at week 12 [2][9] - The trial included patients on optimized antihypertensive regimens, demonstrating that lorundrostat is effective regardless of the number of baseline medications [2][3] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR) [2][3] - Adverse events reported in the trials included a modest increase in serum potassium and a decrease in eGFR, with one serious adverse event of hyponatremia possibly related to the study drug [8][9] Future Developments - Mineralys plans to present additional data from the Phase 3 Launch-HTN trial at an upcoming medical conference and in a peer-reviewed publication [4] - The ongoing Transform-HTN trial will provide further safety and efficacy data as subjects continue to receive lorundrostat [4]

Core Insights - Lorundrostat has shown significant efficacy in reducing blood pressure in patients with uncontrolled or resistant hypertension, achieving a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction at week 12 [1][3] - The drug is a highly selective aldosterone synthase inhibitor, targeting aldosterone biosynthesis rather than blocking mineralocorticoid receptors, positioning it as a potential best-in-class treatment for high-risk patients [1][12] - The favorable safety and tolerability profile of lorundrostat, with low discontinuation rates and manageable on-target effects, supports its use in a specialist setting for complex hypertension cases [6][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial assessing lorundrostat's efficacy as an add-on therapy to existing antihypertensive medications [3][14] - At week 4, lorundrostat 50 mg demonstrated an 11.5 mmHg absolute change and a 5.3 mmHg placebo-adjusted change in 24-hour average systolic blood pressure [4] - A significant proportion of patients (41%) achieved a 24-hour average systolic blood pressure of less than 125 mmHg at week 4 compared to 18% on placebo [5] Safety and Tolerability Results - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), and a low incidence of serious adverse events [6][10] - The incidence of hyperkalemia was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg doses, respectively, after excluding spurious results [10] - The study population included a high proportion of historically underrepresented individuals, with 40% women and 53% Black patients, highlighting the drug's potential impact on diverse demographics [7] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company plans to present additional data from the pivotal Phase 3 Launch-HTN trial at upcoming medical conferences and in peer-reviewed publications [7] - Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, emphasizing its commitment to addressing significant unmet needs in hypertension care [15]

– Lorundrostat 50 mg dose achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001), assessed by 24hr ABPM at week 12, with favorable safety and tolerability profile – – Lorundrostat is a highly selective aldosterone synthase inhibitor that disrupts aldosterone biosynthesis rather than blocking the mineralocorticoid receptor – – Data from Advance-HTN support the potential of lorundrostat as a best-in-class treatment for high-risk patients with uncontrolled or resistant hypert ...

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [1][3] - The company will host a conference call featuring Dr. Luke Laffin from the Cleveland Clinic to discuss results from the Advance-HTN and Launch-HTN clinical trials, highlighting the unmet medical needs in uncontrolled and resistant hypertension [1] Company Overview - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3] - The company's lead product candidate, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3] Upcoming Events - A conference call and webinar will take place on April 1st at 8:00 a.m. ET, where a live webcast will also be available on the company's Investor Relations page [2]

RADNOR, Pa., March 18, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the closing of the sale of an additional 1,944,444 shares of its common stock at a public offering price of $13.50 per share pursuant to the exercise in full of the underwriters’ option to ...

RADNOR, Pa., March 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea and other diseases driven by dysregulated aldosterone, today announced that data from the Phase 2 Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be pres ...

Core Viewpoint - Mineralys Therapeutics, Inc. has announced a public offering of 12,962,962 shares at a price of $13.50 per share, aiming to raise approximately $175.0 million before expenses [1][3]. Group 1: Offering Details - The public offering is expected to close on or about March 13, 2025, pending customary closing conditions [1]. - The underwriters have a 30-day option to purchase an additional 1,944,444 shares [1]. - The offering is being managed by BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities as joint book-running managers [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used 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 [3]. Group 3: Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor targeting cardiorenal conditions [6].

Group 1 - The article discusses Mineralys Therapeutics (NASDAQ: MLYS) and its upcoming hypertension data readout expected in the second half of 2024 [2] - The author runs a pharmaceutical service called Biotech Analysis Central, which provides in-depth analysis of various pharmaceutical companies [2] - The service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Mineralys Therapeutics or the broader industry [1][3][4]

Core Viewpoint - Mineralys Therapeutics, Inc. has announced a public offering of $250 million in common stock to fund clinical development and other corporate purposes [1][3]. Group 1: Offering Details - The company is commencing an underwritten public offering of $250 million, with an option for underwriters to purchase an additional $37.5 million [1]. - The offering is subject to market conditions and there is no assurance regarding its completion or terms [1]. - Joint book-running managers for the offering include BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities [3]. - Additional funds will be allocated for working capital and general corporate purposes [3]. Group 3: Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [6].