---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-26-000054"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2026-03-12T23:59:59+00:00"
generated_at: "2026-05-15T13:55:23.801398+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Mineralys Therapeutics reports Q4/FY2025 results; FDA accepts lorundrostat NDA, PDUFA Dec 22, 2026

## Summary
- FDA accepted NDA for lorundrostat for hypertension; PDUFA target date December 22, 2026.
- Cash, cash equivalents and investments totaled $656.6M at Dec 31, 2025, expected to fund operations into 2028.
- Net loss for FY2025 was $154.7M vs $177.8M in FY2024; Q4 net loss $32.2M vs $48.9M.
- Explore-OSA Phase 2 trial did not meet primary AHI endpoint at 4 weeks; showed clinically meaningful BP reduction.
- R&D expenses fell to $132.0M in FY2025 from $168.6M in FY2024, driven by conclusion of pivotal program.

## SEC filing metadata
- accession: 0001933414-26-000054
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2026-03-12T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000054/0001933414-26-000054-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000054/mlys-20260312.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-26-000054
- JSON: https://secwatch.observer/filing/0001933414-26-000054.json
- Plain text: https://secwatch.observer/filing/0001933414-26-000054.txt

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