MLYS
Mineralys Therapeutics is a biopharmaceutical company developing lorundrostat, an orally administered aldosterone synthase inhibitor small molecule, for cardiorenal conditions including hypertension, chronic kidney disease, and obstructive sleep apnea. Lorundrostat has completed five clinical trials including two pivotal Phase 3 trials (Launch-HTN and Advance-HTN) demonstrating clinically meaningful reductions in systolic blood pressure, and Mineralys submitted an NDA in December 2025 with an FDA PDUFA target action date of December 22, 2026. Additional Phase 2 data from the Explore-CKD trial showed significant reductions in systolic blood pressure and urinary albumin creatinine ratio in patients with hypertension and chronic kidney disease.