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.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Mineralys Therapeutics, Inc. reported the quarter ended December 31, 2025 results: net income $32.2 million.

Period: the quarter ended December 31, 2025
Net income: $32.2 million
Result: reported results

Exact text from the filing

Net loss was $32.2 million for the quarter ended December 31, 2025

View on SEC.gov

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Mineralys Therapeutics, Inc. reported the year ended December 31, 2025 results: net income $154.7 million.

Period: the year ended December 31, 2025
Net income: $154.7 million
Result: reported results

Exact text from the filing

Net loss was $154.7 million for the year ended December 31, 2025

View on SEC.gov

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Source: SEC EDGAR

accession 0001933414-26-000054

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