secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2026-03-12T23:59:59+00:00
Accession:  0001933414-26-000054
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000054/0001933414-26-000054-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000054/mlys-20260312.htm
  HTML page:      https://secwatch.observer/filing/0001933414-26-000054

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer