Mineralys Therapeutics announced on September 5, 2025, the presentation of new subgroup analyses from its Phase 3 Launch-HTN trial at the American Heart Association (AHA) Hypertension Scientific Sessions. These analyses evaluated lorundrostat's efficacy and safety in difficult-to-treat and high-risk patient populations.
The data demonstrated consistent, statistically significant, and clinically meaningful blood pressure reductions across diverse subgroups, including Black or African American adults (29%), older adults (41%), women (47%), and participants with comorbid obesity (63%). These groups often face heightened risk of poor cardiovascular outcomes.
The favorable safety and tolerability profile observed was consistent with the overall study population, with no new safety signals. The company also confirmed plans for a pre-NDA meeting with the FDA in Q4 2025 and an NDA filing in Q4 2025 or Q1 2026, reinforcing a clear regulatory path for lorundrostat.
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