secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2025-03-10T23:59:59+00:00
Accession:  0001628280-25-011459
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Lorundrostat meets primary endpoints in Launch-HTN Phase 3 & Advance-HTN Phase 2 with significant BP reduction
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- Launch-HTN Phase 3: 50 mg lorundrostat achieved 9.1 mmHg placebo-adjusted SBP reduction (p<0.0001) at week 6 and 11.7 mmHg at week 12.
- Advance-HTN Phase 2: 50 mg achieved 7.9 mmHg placebo-adjusted SBP reduction by 24hr ABPM at week 12 (p<0.0001).
- Safety profile favorable: SAEs 2.2% (50 mg) vs 3.0% placebo; hyperkalemia (>6.0 mmol/L) 1.1% in Launch-HTN, 5.3% in Advance-HTN.
- Diverse enrollment: Launch-HTN 47% women, 29% Black/African American; Advance-HTN 40% women, 50% Black/African American.
- Full Advance-HTN results to be presented at ACC Scientific Sessions on March 29, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000162828025011459/0001628280-25-011459-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000162828025011459/mlys-20250310.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-011459

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