Mineralys revises primary endpoints for two pivotal hypertension trials; topline data expected Q4 2024 and H2 2025

Mineralys Therapeutics, Inc.

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.

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