Mineralys files NDA for lorundrostat, expects Explore-OSA data Q1 2026

Mineralys Therapeutics, Inc.

Filed new drug application for lorundrostat with FDA in late 2025.
Topline results from Phase 2 Explore-OSA trial in hypertension & moderate-severe OSA expected Q1 2026.
Phase 2 Explore-CKD met primary endpoint on systolic BP reduction and showed meaningful proteinuria reduction.
Phase 3 Launch-HTN and Advance-HTN trials both met primary endpoints in uncontrolled/resistant hypertension.
Management to participate in LifeSci Partners Corporate Access event Jan 12-14, 2026.

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