---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-26-000082"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2026-05-06T23:59:59+00:00"
generated_at: "2026-05-14T23:01:18.775083+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Mineralys Therapeutics Q1 net loss $39.3M; FDA accepts lorundrostat NDA with Dec 22, 2026 PDUFA

## Summary
- Net loss $39.3M for Q1 2026 vs $42.2M Q1 2025; cash $646.1M, sufficient into 2028.
- FDA accepted NDA for lorundrostat in hypertension; PDUFA target date Dec 22, 2026.
- R&D expenses $24.4M (down 36% YoY) due to conclusion of pivotal program; G&A $21.0M (up 218% YoY) on pre-commercial costs.
- Pre-commercial activities underway: market access, medical advocacy, sales prep for potential launch.
- Conference call at 4:30 p.m. ET today; webcast available on company website.

## SEC filing metadata
- accession: 0001933414-26-000082
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2026-05-06T23:59:59+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/1933414/000193341426000082/0001933414-26-000082-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000082/mlys-20260506.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-26-000082
- JSON: https://secwatch.observer/filing/0001933414-26-000082.json
- Plain text: https://secwatch.observer/filing/0001933414-26-000082.txt

## Source-grounded claims
- claim_id: 7e484f7ee95fe0492257ddea5f1ecc7fcd9f65b5
  claim: Mineralys Therapeutics, Inc. reported the first quarter ended March 31, 2026 results: net income Net loss was $39.3 million for the quarter ended March 31, 2026.
  evidence_excerpt: On May 6, 2026, Mineralys Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026 and provided a corporate update.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1933414/000193341426000082/0001933414-26-000082-index.htm

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