Mineralys Therapeutics reports lorundrostat achieved significant systolic blood pressure reductions in Phase 3 trials ahead of FDA review.
Mineralys Therapeutics (NASDAQ:MLYS) announced Phase 3 trial results for lorundrostat, demonstrating placebo-adjusted systolic blood pressure reductions of 9.6 mmHg in chronic kidney disease (CKD) patients and 12.2 mmHg in non-CKD participants over 12 weeks.
The data, presented at the European Meeting on Hypertension, also showed a 52.2% decrease in urine albumin-to-creatinine ratio for patients with baseline albuminuria. The drug maintained a strong safety profile, with minimal hyperkalemia cases reported.
The FDA is currently reviewing lorundrostat, with a PDUFA target action date set for December 22, 2026. The company aims to secure regulatory approval for high-risk patient groups.