Mineralys Reports $656.6M Cash, FDA Accepts Lorundrostat NDA with Dec 22, 2026 PDUFA
Mineralys closed 2025 with $656.6 million in cash and investments, cut R&D spending to $132.0 million from $168.6 million, and narrowed net loss to $154.7 million from $177.8 million. FDA accepted its NDA for lorundrostat in hypertension with a December 22, 2026 PDUFA date, and an exploratory OSA study showed an 11.1 mmHg placebo-adjusted BP reduction.
1. NDA Acceptance and Clinical Data
Mineralys received FDA acceptance of its NDA for lorundrostat in adults with hypertension, assigning a PDUFA target date of December 22, 2026. The NDA followed five positive clinical trials showing meaningful blood pressure reductions and a favorable safety profile. In an exploratory Phase 2 OSA trial involving 48 participants (mean BMI 38.2 kg/m2, AHI 48.5, systolic BP 142.3 mmHg), 50 mg evening dosing delivered an 11.1 mmHg placebo-adjusted BP reduction over four weeks with no serum potassium excursions above 5.5 mmol/L. An open-label extension trial is ongoing to gather long-term safety and efficacy data.
2. Q4 and Full Year 2025 Financial Results
As of December 31, 2025, Mineralys held $656.6 million in cash, cash equivalents and investments, supporting operations into 2028. Full-year R&D expenses declined to $132.0 million from $168.6 million due to the completion of pivotal programs, while G&A expenses rose to $38.6 million driven by headcount growth and higher compensation. Net loss narrowed to $154.7 million from $177.8 million, aided by lower R&D spending and increased investment income.