News

(RTTNews) - Mineralys Therapeutics Inc. (MLYS) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs.

The regulatory agency's decision on Lorundrostat for the proposed indication is expected on December 22, 2026.

The NDA submission was based on three positive clinical trials of Lorundrostat, which demonstrated safety and 24-hour blood pressure control in adults with hypertension.

Lorundrostat, is an orally administered, selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as chronic kidney disease (CKD) and Obstructive sleep apnea (OSA).

In parallel, the firm also announced topline results from its Phase 2 exploratory trial of Lorundrostat in overweight or obese adults with moderate-to-severe obstructive sleep apnea and hypertension, dubbed Explore-OSA.

Obstructive Sleep Apnea is a common sleep disorder characterized by repeated breathing pauses and starts during sleep due to blockage of the upper airway.

In the study, after four weeks of treatment, Lorundrostat 50 mg administered in the evening did not show a clinically meaningful difference compared with placebo in the *apnea-hypopnea index (AHI), the primary endpoint. However, the treatment resulted in a clinically meaningful reduction in blood pressure and demonstrated favorable safety and tolerability among participants with difficult-to-control hypertension.

*Apnea-Hypopnea Index (AHI), a clinical metric used in sleep studies to diagnose and assess the severity of obstructive sleep apnea (OSA), describes the number of times a person's breathing slows or stops during an average hour of sleep (Source: SleepApnea.org).

Commenting on the trial results, Jon Congleton, CEO of Mineralys Therapeutics, said, "While the Explore-OSA trial did not demonstrate a reduction in AHI, the blood pressure reductions and safety profile were clinically meaningful, especially for this difficult to control population. We believe lorundrostat has the potential to become an important new treatment option for resistant and uncontrolled hypertension, and we look forward to working with the FDA as we advance toward potential approval".

The company is scheduled to report its financial results for the fourth quarter and full year 2025 on March 12, 2026.

MLYS has traded between $10.44 and $47.65 in the last year. The stock closed Monday's trade at $27.25, up 2.44%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.