– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of dysregulated aldosterone in disease onset and progression – – Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication – RADNOR, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focu ...

RADNOR, Pa., March 25, 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, today announced it will host a conference call and webinar featuring Dr. Luke Laffin of the Cleveland Clinic, who will discuss the latest results from the pivotal Advance-HTN and Launch-HTN clinical trials, ...

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].

On Monday, Mineralys Therapeutics, Inc. MLYS released topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials of lorundrostat for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).Both trials achieved statistical significance, were clinically meaningful in their prespecified primary efficacy endpoints, and demonstrated a favorable safety and tolerability profile.The Launch-HTN trial met the primary endpoint with lorundrostat 50 mg dose achieved a 16.9 mmHg red ...

Core Insights - Mineralys Therapeutics announced positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, demonstrating significant efficacy and safety in treating uncontrolled and resistant hypertension [2][3] Efficacy Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at week 6 and a 19.0 mmHg reduction at week 12, with placebo-adjusted reductions of 9.1 mmHg and 11.7 mmHg respectively (p-value < 0.0001) [1][5] - The Advance-HTN trial reported a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12 [1][6] - Both trials demonstrated clinically meaningful and statistically significant results, supporting the potential of lorundrostat as a new treatment option for approximately 15 to 20 million patients with uncontrolled hypertension in the U.S. [3][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety and tolerability profile across both pivotal trials, with low incidences of serious adverse events and manageable side effects [8][14] - The incidence of hyperkalemia was reported at 1.1% and 1.5% in the Launch-HTN trial and 5.3% and 7.4% in the Advance-HTN trial [14] Future Developments - Full results from the Advance-HTN trial are scheduled to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions [1][7] - The ongoing Transform-HTN open-label extension trial will continue to gather safety and efficacy data for lorundrostat [10] Company Overview - Mineralys Therapeutics is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, with lorundrostat being its lead candidate [2][19] - The company aims to address the significant unmet medical need in hypertension, where less than 50% of patients achieve their blood pressure goals with current medications [12][13]

Core Insights - Mineralys Therapeutics, Inc. is set to announce topline results from its pivotal trials, Launch-HTN and Advance-HTN, on March 10, 2025 [1] Group 1: 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 [5] - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [5] Group 2: Trial Details - The Launch-HTN trial assessed the efficacy and safety of lorundrostat as an add-on therapy for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) in patients already on two to five antihypertensive medications [2] - The Advance-HTN trial evaluated lorundrostat's efficacy and safety when used as an add-on therapy for uHTN or rHTN with a standardized background treatment of two or three antihypertensive medications [3]