RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) reported a series of positive clinical milestones and second-quarter 2025 financial results, positioning its lead drug candidate, lorundrostat, for a potential new drug application (NDA) following multiple successful trials in hypertension and related conditions.
The company confirmed it will hold a pre-NDA meeting with the U.S. Food and Drug Administration in the fourth quarter, following favorable outcomes from its pivotal Phase 3 Launch-HTN and Advance-HTN trials. Both studies met primary endpoints, showing lorundrostat’s efficacy and safety in patients with uncontrolled or resistant hypertension. Results were published in the Journal of the American Medical Association and the New England Journal of Medicine, and presented at major cardiology and hypertension conferences.
Mineralys also reported success in its Phase 2 Explore-CKD trial, which tested lorundrostat in patients with hypertension, reduced kidney function, and albuminuria. The drug achieved a statistically significant placebo-adjusted reduction of 7.5 mmHg in systolic blood pressure and a 25.6% drop in urine albumin-to-creatinine ratio after four weeks, alongside a favorable safety profile.
“Our clinical program has positioned us to move ahead with our NDA strategy,” said CEO Jon Congleton. “These data further support our belief that lorundrostat has significant potential to be a leading new therapy to control hypertension and reduce cardiovascular risk.”
Additional studies are ongoing, including the Transform-HTN open-label extension trial to gather long-term safety data and the Explore-OSA Phase 2 trial in patients with obstructive sleep apnea and hypertension, with topline results expected in the first half of 2026.
Financially, Mineralys ended the quarter with $324.9 million in cash, cash equivalents, and investments, up from $198.2 million at year-end 2024, providing runway into 2027. R&D expenses fell slightly to $38.3 million from $39.3 million a year earlier, reflecting the conclusion of pivotal programs. G&A expenses rose to $8.5 million from $5.9 million, driven by higher headcount and compensation. The company posted a net loss of $43.3 million, compared to $41.0 million in the same quarter last year.
With pivotal trial data in hand, a Phase 3-ready pipeline, and a strong cash position, Mineralys is now moving into the regulatory phase for lorundrostat, aiming to bring a new treatment option to patients with hard-to-control hypertension.
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