Clinical Trial Results: Post‑hoc analysis of Phase 3 Launch‑HTN trial (800 participants) showed placebo‑adjusted systolic BP reduction of 9.6 mmHg in 192 CKD patients and 12.2 mmHg in non‑CKD patients at week 12. Target SBP <130 mmHg achieved by 44% of CKD vs 18% placebo; 48% vs 22% in non‑CKD.
Renal Outcomes: In 84 CKD participants with baseline albuminuria, lorundrostat produced a 52.2% placebo‑adjusted reduction in urinary albumin‑to‑creatinine ratio. Confirmed hyperkalemia occurred in 2.4% of CKD patients and 0% of non‑CKD patients.
Company Valuation & Market Reaction: Mineralys valued at $2.6 billion; stock up 102% over past year despite being unprofitable. Analysts price targets $30‑$56; InvestingPro notes overvaluation relative to fair value. Company holds more cash than debt.
Regulatory Status: Lorundrostat under FDA review with target decision date 22 December 2026.
Financial Update: Q1 2026 EPS of –$0.47 beat forecast of –$0.81 (41.98% beat). NDA accepted for lorundrostat. Strong cash reserves disclosed.
Corporate Governance: 2026 annual meeting elected three Class III directors – Srinivas Akkaraju, MD PhD; Brian Taylor Slingsby, MD PhD MPH; Daphne Karydas – to three‑year terms ending 2029.
