Mineralys submits NDA for lorundrostat, raises $578M, 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 $578M across three equity offerings in 2025: $269.6M at $25.50/share (Sept), $188.7M at $13.50/share (March), and $119.4M via ATM at $29.49 avg. Cash position increased from $198.2M to $656.6M, 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 →