MINERALYS THERAPEUTICS INC (MLYS)
Health Care · Biopharmaceutical / Aldosterone regulation therapy · NASDAQ
Mineralys is a clinical-stage biopharmaceutical company pursuing FDA approval of lorundrostat, a selective aldosterone synthase inhibitor targeting resistant hypertension and related cardiorenal diseases.
What MINERALYS THERAPEUTICS INC does
Mineralys Therapeutics is a biopharmaceutical company developing lorundrostat, a proprietary oral aldosterone synthase inhibitor designed to treat diseases driven by dysregulated aldosterone, particularly resistant and uncontrolled hypertension and related cardiorenal conditions. The company submitted a New Drug Application (NDA) to the FDA in December 2025 for lorundrostat for hypertension treatment in combination with other antihypertensive drugs, with a PDUFA target action date of December 22, 2026. Lorundrostat has completed five successful clinical trials supporting efficacy and safety, including two pivotal Phase 3 trials (Launch-HTN and Advance-HTN) demonstrating robust blood pressure reductions.
Themes: ["Resistant/uncontrolled hypertension","Chronic kidney disease (CKD)","Obstructive sleep apnea (OSA)","Aldosterone-driven cardiorenal disease","Blood pressure management"]
Fundamentals
- Price$28.96 as of 2026-07-09 close
- Market cap$2.7B as of 2026-07-10
- 1-year return+117.9% as of 2026-07-09 close
- ROE-27.9% as of 2026-07-10
- Debt / equity0.00 as of 2026-07-10
- Beta0.56 as of 2026-07-10
Key risks (from latest filing)
["FDA approval risk: NDA submission for lorundrostat faces approval uncertainty with PDUFA decision date of December 22, 2026; failure to obtain approval would eliminate primary commercial opportunity","Clinical development risk: Additional trials in CKD and OSA indications show mixed results (Explore-OSA failed to meet primary AHI endpoint), limiting expansion potential beyond hypertension","Competition risk: Aldosterone inhibitor market includes established competitors like spironolactone and eplerenone, and other pipeline ASI candidates from larger pharmaceutical companies"]
Competitors & peers
- Spironolactone (established aldosterone antagonist)
- Eplerenone (established aldosterone antagonist)
- Finerenone (Kerendia — patiromer, SGLT2 inhibitors in CKD space)
Fundamentals: Finnhub, as of 2026-07-10. Filings: SEC EDGAR. Prices are delayed daily-close data.
Last updated 2026-07-09.
Informational only — NOT financial advice. All figures are delayed daily-close data from SEC EDGAR & Finnhub, shown with their as-of date.