Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is progressing towards filing a new drug application (NDA) for its leading drug candidate, lorundrostat, following a series of successful clinical trials targeting hypertension. The company announced positive results from pivotal trials, which positioned lorundrostat as a promising new treatment option for patients with uncontrolled or resistant hypertension. A pre-NDA meeting with the U.S. Food and Drug Administration is scheduled for the fourth quarter of 2025.
The pivotal Phase 3 trials, known as Launch-HTN and Advance-HTN, demonstrated that lorundrostat significantly met its primary endpoints. These trials confirmed the drug’s efficacy and safety in treating patients with challenging hypertension cases. Results were disseminated in reputable medical journals, including the Journal of the American Medical Association and the New England Journal of Medicine, and presented at significant cardiology and hypertension conferences.
In addition to the Phase 3 successes, Mineralys reported positive outcomes from its Phase 2 Explore-CKD trial, which involved patients suffering from hypertension, reduced kidney function, and albuminuria. The trial indicated that lorundrostat achieved a statistically significant placebo-adjusted reduction of 7.5 mmHg in systolic blood pressure, along with a 25.6% decrease in urine albumin-to-creatinine ratio after four weeks. The study also highlighted a favorable safety profile for the medication.
“Our clinical program has positioned us to move ahead with our NDA strategy,” stated Jon Congleton, CEO of Mineralys. “These data further support our belief that lorundrostat has significant potential to be a leading new therapy to control hypertension and reduce cardiovascular risk.”
As part of its ongoing research efforts, the company is conducting additional studies, including the Transform-HTN open-label extension trial focused on long-term safety data, and the Explore-OSA Phase 2 trial examining lorundrostat in patients with obstructive sleep apnea and hypertension. Topline results from these studies are anticipated in the first half of 2026.
Financially, Mineralys reported a cash position of $324.9 million at the end of the second quarter of 2025, a noticeable increase from $198.2 million at the conclusion of 2024. This funding provides a solid runway into 2027. Research and development expenses saw a slight decrease to $38.3 million, down from $39.3 million in the previous year, reflecting the conclusion of pivotal programs. Conversely, general and administrative expenses rose to $8.5 million, up from $5.9 million, largely due to increased headcount and compensation. The company reported a net loss of $43.3 million, compared to $41.0 million in the same quarter the previous year.
With robust trial data, a well-prepared pipeline for Phase 3, and strong financial backing, Mineralys Therapeutics is poised to enter the regulatory phase for lorundrostat, aiming to provide a new therapeutic option for patients facing difficult-to-manage hypertension.
