net income -$154.7M. Mineralys submits NDA for lorundrostat, targets Dec 2026 approval

Filed March 12, 2026 · Period ending December 31, 2025 · Compared to 10-K Feb 12, 2025 · ~1 min read

Key Changes

• high

  Company submitted NDA for lorundrostat in Dec 2025; FDA accepted with PDUFA target date of Dec 22, 2026. Two pivotal trials (Launch-HTN, Advance-HTN) met primary endpoints with statistically significant BP reductions, published in NEJM and JAMA.

  Business: NDA submission verify on EDGAR →
• high

  Raised across three equity offerings in 2025: at (Sept), at (March), and via ATM at avg. Cash position increased, extending runway through approval and commercialization.

  MD&A: Capital raises verify on EDGAR →
• medium

  Explore-CKD trial showed statistically significant reduction in UACR (kidney disease marker) alongside BP reduction, supporting potential label expansion. Explore-OSA trial missed primary endpoint (AHI) but demonstrated BP benefit.

  Business: Phase 2 trials verify on EDGAR →