Mineralys Therapeutics (MLYS) said Friday that new analysis from its phase 3 trial evaluating lorundrostat in uncontrolled or resistant hypertension showed "statistically significant and clinically meaningful" reductions in blood pressure compared with placebo.
The study, which enrolled 1,083 participants, also showed favorable safety and tolerability outcomes across all groups in the trial, with no new safety signals observed and adverse events were generally mild or moderate, the company said.
Mineralys said it has scheduled a meeting with the US Food and Drug Administration in Q4, ahead of filing a new drug application either in Q4 or in Q1 of 2026.
Shares of the company were up more than 1% in recent trading Friday.
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