Successful Clinical Trial Outcomes
Lorundrostat demonstrated a clinically meaningful and sustained reduction in systolic blood pressure in both Launch-HTN and Advance-HTN pivotal trials, with consistent, statistically significant reductions across diverse patient populations, including subgroups like African-Americans and women.
Strong Financial Position
Mineralys ended the quarter with $593.6 million in cash, cash equivalents, and investments, sufficient to fund planned clinical trials and regulatory activities into 2028.
Reduction in Net Loss
Net loss decreased to $36.9 million for the quarter, compared to $56.3 million in the same quarter last year, primarily due to a decrease in R&D expenses.
Promising Exploratory Trials
The Explore-CKD trial showed a clinically meaningful reduction in systolic BP and was well tolerated, with 77% of surveyed healthcare professionals indicating they would consider prescribing lorundrostat to CKD patients with uncontrolled hypertension.
Preparation for NDA Submission
Mineralys received pre-NDA feedback from the FDA with no surprises and is moving ahead with its NDA filing for lorundrostat, expected either late in the current quarter or in the first quarter of 2026.