Mineralys Therapeutics, Inc.MLYS
What Mineralys Therapeutics, Inc. does.
We are a biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone. Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA).
In the United States, there are approximately 120 million patients with sustained elevated blood pressure (BP), or hypertension. Approximately 60 million patients are treated and over 30 million do not achieve their BP goal, with approximately 20 million having systolic BP levels greater than 140 mmHg. Patients with hypertension that persists despite taking two or more medications have 1.8 and 2.5 times greater mortality risk due to either cardiovascular disease or stroke, respectively. Dysregulated aldosterone levels are a key factor in uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) in approximately 30% of patients.
Ahead of the NDA submission in December 2025, we completed five successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN or rHTN. This includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable, and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. Based on the positive results from our pivotal program, we submitted an NDA in December 2025 for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.
Revenue and profit, by fiscal year.
| Fiscal year | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|
| Net income | — | -$29.8M | -$71.9M | -$177.8M | -$154.7M |
| Free cash flow | — | — | -$81.2M | -$166.4M | -$142.4M |
More on MLYS.
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Figures from Mineralys Therapeutics, Inc.'s filings with the U.S. SEC, standardised automatically; prices are end-of-day closes. Not financial advice.