secwatch.observer — SEC 8-K summary
======================================

Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2026-03-09T23:59:59+00:00
Accession:  0001933414-26-000048
Event type: regulatory
Sentiment:  neutral
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/0001933414-26-000048-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/mlys-20260306.htm
  HTML page:      https://secwatch.observer/filing/0001933414-26-000048

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer