secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2023-12-22T23:59:59+00:00
Accession:  0001933414-23-000096
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Mineralys doses first subject in Phase 3 Launch-HTN trial; topline data expected 2H 2025
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- First subject dosed in Launch-HTN (NCT06153693), a global Phase 3 trial enrolling up to ~1,000 patients.
- Trial evaluates lorundrostat as add-on for uncontrolled or resistant hypertension on 2-5 background drugs.
- Three arms: placebo, lorundrostat 50 mg QD, or 50 mg titrated to 100 mg QD at week 6.
- Primary endpoint: change in systolic BP vs placebo at 12 weeks by automated office measurement.
- Topline data from Advance-HTN (first pivotal trial) expected in 2H 2024; Transform-HTN OLE ongoing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341423000096/0001933414-23-000096-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341423000096/mlys-20231221.htm
  HTML page:      https://secwatch.observer/filing/0001933414-23-000096

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