Mineralys Therapeutics, Inc. (MLYS)
NASDAQ (NGS) NASDAQ (NGS) Primary Summary
Mineralys Therapeutics, Inc. (MLYS) Q1 2026 Earnings Call Transcript
Mineralys Therapeutics, Inc. (MLYS) Q1 2026 Earnings Call Transcript
Mineralys Therapeutics, Inc. (MLYS) Q4 2025 Earnings Call Transcript
Mineralys Therapeutics, Inc. (MLYS) Q4 2025 Earnings Call Transcript
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 $593.6 million. MLYS's lorundrostat demonstrated significant efficacy in lowering systolic blood pressure, with compelling results in both real-world and specialty settings. Regulatory risk is reduced following positive pre-NDA FDA feedback and JAMA recognition, with NDA submission expected late 2025 or early 2026.
Mineralys Therapeutics, Inc. Investors
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| CE Curtis Ellergodt Rothschild Investment LLC | 55 | $839.84 | $1,481.93 | $642.09 | 76.45% |
| BG Bart Gancher Intech Investment Management LLC | 11,259 | $408,589.11 | $300,903.53 | -$107,685.58 | -26.36% |
 Anthony Scaramucci SkyBridge Capital II LLC | 1.18M | $34.56M | $31.46M | -$3.11M | -8.99% |
 Point72 Asset Management LP Point72 Asset Management LP | 1.91M | $64.85M | $51.21M | -$13.65M | -21.04% |
 Didric Cederholm Lion Point Capital LP | 10,500 | $122,850 | $280,618.8 | $157,768.8 | 128.42% |
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Mineralys Therapeutics, Inc. Profile
| Biotechnology Industry | Healthcare Sector | Jon Congleton CEO | NASDAQ (NGS) Exchange | 603170101 CUSIP |
| US Country | 76 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.
