Mineralys Therapeutics reports Q4/FY2025 results; FDA accepts lorundrostat NDA, PDUFA Dec 22, 2026

Mineralys Therapeutics, Inc.

FDA accepted NDA for lorundrostat for hypertension; PDUFA target date December 22, 2026.
Cash, cash equivalents and investments totaled $656.6M at Dec 31, 2025, expected to fund operations into 2028.
Net loss for FY2025 was $154.7M vs $177.8M in FY2024; Q4 net loss $32.2M vs $48.9M.
Explore-OSA Phase 2 trial did not meet primary AHI endpoint at 4 weeks; showed clinically meaningful BP reduction.
R&D expenses fell to $132.0M in FY2025 from $168.6M in FY2024, driven by conclusion of pivotal program.

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