---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-23-000096"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2023-12-22T23:59:59+00:00"
generated_at: "2026-06-07T08:23:20.914719+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Mineralys doses first subject in Phase 3 Launch-HTN trial; topline data expected 2H 2025

## Summary
- First subject dosed in Launch-HTN (NCT06153693), a global Phase 3 trial enrolling up to ~1,000 patients.
- Trial evaluates lorundrostat as add-on for uncontrolled or resistant hypertension on 2-5 background drugs.
- Three arms: placebo, lorundrostat 50 mg QD, or 50 mg titrated to 100 mg QD at week 6.
- Primary endpoint: change in systolic BP vs placebo at 12 weeks by automated office measurement.
- Topline data from Advance-HTN (first pivotal trial) expected in 2H 2024; Transform-HTN OLE ongoing.

## SEC filing metadata
- accession: 0001933414-23-000096
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2023-12-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341423000096/0001933414-23-000096-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341423000096/mlys-20231221.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-23-000096
- JSON: https://secwatch.observer/filing/0001933414-23-000096.json
- Plain text: https://secwatch.observer/filing/0001933414-23-000096.txt

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