---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-26-000002"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2026-01-06T23:59:59+00:00"
generated_at: "2026-05-16T11:34:09.731860+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001933414-26-000002
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2026-01-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000002/0001933414-26-000002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000002/mlys-20260106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-26-000002
- JSON: https://secwatch.observer/filing/0001933414-26-000002.json
- Plain text: https://secwatch.observer/filing/0001933414-26-000002.txt

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