Mineralys Therapeutics, Inc. announced fourth quarter and full year 2025 financial results, reporting net loss of $32.2 million for Q4 and $154.7 million for the year, with cash position of $656.6 million as of December 31, 2025. The FDA accepted the NDA for lorundrostat for hypertension treatment, assigning a PDUFA target date of December 22, 2026.
Key takeaways
FDA accepted NDA for lorundrostat in adults with hypertension; PDUFA target date December 22, 2026
Cash, cash equivalents and investments $656.6 million as of December 31, 2025
Q4 2025 net loss $32.2 million vs $48.9 million in Q4 2024
Full year 2025 net loss $154.7 million vs $177.8 million in 2024
R&D expenses Q4 2025 $24.4 million vs $44.6 million Q4 2024; full year $132.0 million vs $168.6 million
Explore-OSA Phase 2 trial: no meaningful AHI reduction but 11.1 mmHg systolic BP reduction with lorundrostat