Mineralys Therapeutics Announces Positive Results from Key Hypertension Trials and Prepares for FDA Pre-NDA Meeting in 4Q 2025

Reuters
Aug 13
Mineralys <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces Positive Results from Key Hypertension Trials and Prepares for FDA Pre-NDA Meeting in 4Q 2025

Mineralys Therapeutics Inc. has announced the successful achievement of statistical significance in its Explore-CKD Phase 2 trial, which focused on reducing systolic blood pressure and urinary albumin-to-creatinine ratio (UACR) while demonstrating a favorable safety profile. The company also continues its Explore-OSA Phase 2 trial involving participants with obstructive sleep apnea (OSA) and hypertension, with topline results anticipated in the first half of 2026. Additionally, Mineralys has presented positive results from its Launch-HTN and Advance-HTN pivotal trials at scientific meetings and published them in JAMA and NEJM. The company is preparing for a pre-NDA meeting with the FDA, scheduled for the fourth quarter of 2025, as part of its strategy to advance the development of lorundrostat for treating hypertension and related conditions.

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