secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2024-06-10T23:59:59+00:00
Accession:  0001933414-24-000025
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mineralys revises primary endpoints for two pivotal hypertension trials; topline data expected Q4 2024 and H2 2025
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- FDA agreed to change Launch-HTN primary endpoint to automated office systolic BP at 6 weeks, pooled 50 mg QD; topline data expected H2 2025.
- Plan similar revision for Advance-HTN (Phase 2) pending FDA alignment: 24-hour ambulatory systolic BP at 4 weeks, pooled 50 mg QD; topline Q4 2024.
- Both trials evaluate lorundrostat for uncontrolled or resistant hypertension; no other design changes or operational impact.
- Launch-HTN Phase 3 enrolls up to 1,000 subjects; Advance-HTN Phase 2 had 261 subjects.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341424000025/0001933414-24-000025-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341424000025/mlys-20240610.htm
  HTML page:      https://secwatch.observer/filing/0001933414-24-000025

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