Mineralys Therapeutics Inc
NASDAQ:MLYS
Mineralys Therapeutics Inc
Mineralys Therapeutics, Inc. s a clinical-stage biopharmaceutical company engages in developing medicines to target disease, driven by abnormally elevated aldosterone. The company is headquartered in Radnor, Pennsylvania and currently employs 12 full-time employees. The company went IPO on 2023-02-10. The firm is focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is initially developing for the treatment of patients with uncontrolled hypertension (uHTN). The firm completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uHTN. The company intends to develop lorundrostat for the treatment of chronic kidney disease (CKD).
Mineralys Therapeutics, Inc. s a clinical-stage biopharmaceutical company engages in developing medicines to target disease, driven by abnormally elevated aldosterone. The company is headquartered in Radnor, Pennsylvania and currently employs 12 full-time employees. The company went IPO on 2023-02-10. The firm is focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is initially developing for the treatment of patients with uncontrolled hypertension (uHTN). The firm completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uHTN. The company intends to develop lorundrostat for the treatment of chronic kidney disease (CKD).
NDA Submission: Mineralys plans to submit the NDA for lorundrostat either late this quarter or in the first quarter of 2026, following favorable pre-NDA feedback from the FDA with no surprises.
Clinical Success: Pivotal trials (Launch-HTN and Advance-HTN) showed lorundrostat delivers sustained and meaningful reductions in systolic blood pressure, including in diverse and difficult-to-treat populations.
Comorbidity Data: New data from the Explore-CKD trial showed lorundrostat reduces blood pressure and urinary albumin creatinine ratio in CKD patients, and Explore-OSA trial results are expected in Q1 2026.
Financial Strength: Mineralys ended Q3 with $593.6 million in cash and investments, expected to fund operations into 2028.
Reduced Expenses: R&D expenses declined significantly as the pivotal program concluded, resulting in a narrower net loss year-over-year.
Partnering Focus: Management emphasized ongoing partnership discussions, especially for ex-U.S. opportunities and commercial scale-up.
