---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-25-000070"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2025-06-17T23:59:59+00:00"
generated_at: "2026-05-19T05:16:48.906971+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Positive Phase 2 Explore-CKD results for lorundrostat; primary endpoint met

## Summary
- 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.

## SEC filing metadata
- accession: 0001933414-25-000070
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2025-06-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000070/0001933414-25-000070-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000070/mlys-20250617.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-25-000070
- JSON: https://secwatch.observer/filing/0001933414-25-000070.json
- Plain text: https://secwatch.observer/filing/0001933414-25-000070.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.