Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has reported a series of significant clinical advancements and financial results for the second quarter of 2025, propelling its lead drug candidate, lorundrostat, toward a potential new drug application (NDA). The company announced plans to meet with the U.S. Food and Drug Administration (FDA) in the fourth quarter, following successful outcomes from its pivotal Phase 3 trials for hypertension.
Both the Launch-HTN and Advance-HTN studies demonstrated that lorundrostat effectively managed patients with uncontrolled or resistant hypertension. These findings were recently published in prestigious journals, including the Journal of the American Medical Association and the New England Journal of Medicine, and were presented at leading conferences in cardiology and hypertension.
In addition to positive results from the Phase 3 trials, the company also reported encouraging data from its Phase 2 Explore-CKD trial. This study evaluated lorundrostat in patients suffering from hypertension, reduced kidney function, and albuminuria. After four weeks, the drug achieved a statistically significant reduction of 7.5 mmHg in systolic blood pressure and a 25.6% decrease in urine albumin-to-creatinine ratio, while maintaining a favorable safety profile.
“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.”
Ongoing studies include the Transform-HTN open-label extension trial, which aims to gather long-term safety data, and the Explore-OSA Phase 2 trial focusing on patients with obstructive sleep apnea and hypertension. Topline results from these studies are anticipated in the first half of 2026.
From a financial perspective, Mineralys ended the quarter with $324.9 million in cash, cash equivalents, and investments, an increase from $198.2 million at the end of 2024. This financial position provides a runway for the company into 2027. Research and development (R&D) expenses decreased slightly to $38.3 million from $39.3 million the previous year, reflecting the conclusion of pivotal programs. However, general and administrative (G&A) expenses rose to $8.5 million from $5.9 million, primarily due to higher compensation and headcount.
The company reported a net loss of $43.3 million, compared to a loss of $41.0 million in the same quarter last year. With pivotal trial data now secured, a Phase 3-ready pipeline, and a robust financial standing, Mineralys is advancing to the regulatory phase for lorundrostat. The aim is to provide a new treatment option for patients facing challenges in controlling hypertension.
As the landscape for hypertension treatments evolves, advancements from companies like Mineralys Therapeutics highlight the ongoing commitment to addressing cardiovascular health challenges. For further updates on developments in Chester County and beyond, follow local news outlets.
