secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2026-01-06T23:59:59+00:00
Accession:  0001933414-26-000002
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000002/0001933414-26-000002-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000002/mlys-20260106.htm
  HTML page:      https://secwatch.observer/filing/0001933414-26-000002

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