---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-26-000048"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2026-03-09T23:59:59+00:00"
generated_at: "2026-05-15T18:12:51.129980+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Mineralys' NDA for hypertension drug lorundrostat; PDUFA Dec 22, 2026

## Summary
- FDA accepted NDA for lorundrostat for hypertension in combination with other antihypertensives; PDUFA target date December 22, 2026.
- Phase 2 Explore-OSA trial did not meet primary endpoint; lorundrostat did not reduce apnea-hypopnea index vs placebo.
- Lorundrostat showed 11.1 mmHg BP reduction vs 1.0 mmHg for placebo (p<0.0001) at week 4; placebo-adjusted reduction 6.2 mmHg (p<0.0003).
- Safety favorable: no serum potassium >5.5 mmol/L; analysis ongoing for other endpoints.
- Company believes lorundrostat has potential for resistant/uncontrolled hypertension; topline data from Explore-OSA reported.

## SEC filing metadata
- accession: 0001933414-26-000048
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2026-03-09T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/0001933414-26-000048-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/mlys-20260306.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-26-000048
- JSON: https://secwatch.observer/filing/0001933414-26-000048.json
- Plain text: https://secwatch.observer/filing/0001933414-26-000048.txt

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