Mineralys Submits First NDA Application for Hypertension
"Mineralys had a transformational year in 2025, defined by significant clinical progress and key regulatory milestones," said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. "We successfully completed multiple clinical trials, with results published in JAMA and The New England Journal of Medicine, highlighting the potential of lorundrostat to benefit patients with inadequately controlled hypertension. We also ended the year with the submission of our first NDA for the treatment of hypertension in adults. The FDA's acceptance of this application marked a significant milestone, and we look forward to working closely with the agency as lorundrostat advances toward potential approval and commercialization."
