Mineralys Therapeutics, Inc. (MLYS) Shows Positive Phase 3 HTN Results, Blood Pressure Drops in High-Risk Groups

We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Mineralys Therapeutics, Inc. is one of them.

Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company, focuses on developing therapies for diseases caused by dysregulated aldosterone, including hypertension, chronic kidney disease (CKD), and obstructive sleep apnea. Its lead candidate, lorundrostat, is an oral, highly selective aldosterone synthase inhibitor designed to treat cardiorenal conditions.

In September 2025, MLYS presented new positive subgroup data from its Phase 3 Launch-HTN trial at the American Heart Association Hypertension Scientific Sessions. The results showed significant and consistent blood pressure reductions in high-risk populations, including Black or African American adults, older adults, women, and patients with comorbid obesity. The data also highlighted a favorable safety and tolerability profile, reinforcing lorundrostat’s potential as a treatment for difficult-to-manage hypertension.

Looking ahead, the business plans a pre-NDA meeting with the FDA later this year, aiming for a New Drug Application filing as early as Q1 2026. This regulatory step is critical for advancing lorundrostat toward potential approval and commercial launch.

To support ongoing clinical and regulatory efforts, Mineralys Therapeutics, Inc. (NASDAQ:MLYS) completed an upsized $287.5 million public offering in early September 2025, strengthening its financial position and enabling continued development.

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