secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2025-06-17T23:59:59+00:00
Accession:  0001933414-25-000070
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Positive Phase 2 Explore-CKD results for lorundrostat; primary endpoint met
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- Lorundrostat 25 mg reduced systolic BP by 9.3 mmHg (–7.5 mmHg placebo-adjusted, p=0.0024) in hypertensive CKD patients.
- UACR reduction of 31% (–25.6% placebo-adjusted, p=0.0015) suggests renal protective potential.
- Favorable safety profile: 3% SAEs (lorundrostat), 5% hyperkalemia rate; 3% discontinuation due to TEAEs.
- Data augment pivotal Phase 3 Launch-HTN and other trials; company plans NDA submission including these results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341425000070/0001933414-25-000070-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341425000070/mlys-20250617.htm
  HTML page:      https://secwatch.observer/filing/0001933414-25-000070

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