---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-24-000025"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2024-06-10T23:59:59+00:00"
generated_at: "2026-06-01T05:23:46.592451+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Mineralys revises primary endpoints for two pivotal hypertension trials; topline data expected Q4 2024 and H2 2025

## Summary
- FDA agreed to change Launch-HTN primary endpoint to automated office systolic BP at 6 weeks, pooled 50 mg QD; topline data expected H2 2025.
- Plan similar revision for Advance-HTN (Phase 2) pending FDA alignment: 24-hour ambulatory systolic BP at 4 weeks, pooled 50 mg QD; topline Q4 2024.
- Both trials evaluate lorundrostat for uncontrolled or resistant hypertension; no other design changes or operational impact.
- Launch-HTN Phase 3 enrolls up to 1,000 subjects; Advance-HTN Phase 2 had 261 subjects.

## SEC filing metadata
- accession: 0001933414-24-000025
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2024-06-10T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341424000025/0001933414-24-000025-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341424000025/mlys-20240610.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-24-000025
- JSON: https://secwatch.observer/filing/0001933414-24-000025.json
- Plain text: https://secwatch.observer/filing/0001933414-24-000025.txt

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