Mineralys Therapeutics, Inc. (MLYS)
NASDAQ (NGS) NASDAQ (NGS) Primary Summary
Mineralys: Pre-NDA Feedback Sets Stage For A Pivotal 2026
Mineralys (MLYS) is transitioning to a pre-commercial stage, supported by robust Phase 3 data and a strengthened cash position of $593.6 million. MLYS's lorundrostat demonstrated significant efficacy in lowering systolic blood pressure, with compelling results in both real-world and specialty settings. Regulatory risk is reduced following positive pre-NDA FDA feedback and JAMA recognition, with NDA submission expected late 2025 or early 2026.
Wall Street Analysts Think Mineralys Therapeutics, Inc. (MLYS) Could Surge 27.55%: Read This Before Placing a Bet
The mean of analysts' price targets for Mineralys Therapeutics, Inc. (MLYS) points to a 27.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Mineralys Therapeutics, Inc. (MLYS) Q3 2025 Earnings Call Transcript
Mineralys Therapeutics, Inc. ( MLYS ) Q3 2025 Earnings Call November 10, 2025 4:30 PM EST Company Participants Jon Congleton - President, CEO & Director Adam Levy - CFO & Secretary David Rodman - Chief Medical Officer Eric Warren Conference Call Participants Daniel Ferry - Lifesci Advisors, LLC Umer Raffat - Evercore ISI Institutional Equities, Research Division Jin Law - Goldman Sachs Group, Inc., Research Division Alice Nettleton - BofA Securities, Research Division Jayed Momin - Stifel, Nicolaus & Company, Incorporated, Research Division Mohit Bansal - Wells Fargo Securities, LLC, Research Division Rami Katkhuda - LifeSci Capital, LLC, Research Division Presentation Operator Greetings, and welcome to Mineralys Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.
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Mineralys Therapeutics, Inc. Profile
| Biotechnology Industry | Healthcare Sector | Jon Congleton CEO | NASDAQ (NGS) Exchange | 603170101 CUSIP |
| US Country | 51 Employees | - Last Dividend | - Last Split | 10 Feb 2023 IPO Date |
Overview
Mineralys Therapeutics, Inc. stands out as a pioneering clinical-stage biopharmaceutical entity that concentrates on innovating therapeutic solutions aimed at addressing hypertension and chronic kidney diseases. Previously recognized as Catalys SC1, Inc., the corporation underwent a significant rebranding to Mineralys Therapeutics, Inc. in May 2020, showcasing its evolving focus and dedication to its specialized field. Having been established in 2019, the company has rapidly positioned itself at the forefront of medical research and development related to cardiorenal conditions from its headquarters in Radnor, Pennsylvania. This transition exemplifies Mineralys Therapeutics' commitment to pushing the boundaries of medical science, specifically targeting conditions that arise from abnormally high aldosterone levels.
Products and Services
- Lorundrostat
Lorundrostat is presented as Mineralys Therapeutics' flagship clinical-stage product candidate, epitomizing the company's innovative approach towards addressing cardiorenal conditions. As a proprietary, orally administered therapy, it distinguishes itself through its highly selective inhibition of aldosterone synthase. This mechanism positions lorundrostat as a potentially transformative solution for managing diseases influenced by elevated aldosterone, a pivotal factor in various cardiorenal conditions. The development and advancement of lorundrostat underscore Mineralys Therapeutics' pledge to fill critical gaps in current treatment paradigms, offering new hope for patients grappling with the challenges of hypertension and chronic kidney diseases.
