Mineralys Therapeutics (NASDAQ:MLYS) has announced changes in the primary endpoint of its ongoing pivotal trials, Advance-HTN and Launch-HTN.

The company intends to modify the primary endpoint for both trials based on recent discussions with the FDA.

The changes aim to assess automated office measured systolic blood pressure at six weeks rather than the initial 12-week period.

This revision, if aligned with the FDA, will also apply to the Advance-HTN trial.

The Advance-HTN and Launch-HTN trials continue to monitor efficacy at 12 weeks for both 50mg and titrated 100mg dosages.

Mineralys anticipates releasing topline data from the Advance-HTN trial in Q4 2024, with data from the Launch-HTN trial expected in the second half of 2025.