secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2023-05-02T23:59:59+00:00
Accession:  0001933414-23-000028
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mineralys first patient dosed in ADVANCE-HTN pivotal trial of lorundrostat for hypertension
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- ADVANCE-HTN trial to enroll up to 300 adults with uncontrolled or resistant hypertension.
- Primary endpoint: change in systolic BP vs placebo after 12 weeks (24-hr ambulatory monitoring).
- Topline data from ADVANCE-HTN expected in first half of 2024.
- Second pivotal Phase 3 trial to begin enrolling H2 2023, data anticipated mid-2025.
- Phase 2 CKD trial for lorundrostat expected to start mid-2023, topline data H1 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341423000028/0001933414-23-000028-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341423000028/mlys202305028k.htm
  HTML page:      https://secwatch.observer/filing/0001933414-23-000028

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