News & Events zu Mineralys Therapeutics Inc (MLYS)MLYSMineralys Therapeutics Inc

Mineralys Therapeutics Presents New Analysis of Lorundrostat Trial

Mineralys Therapeutics announced the presentation of a new analysis from its pivotal Phase 3 Launch-HTN trial, showing that at Week 12, 46% of lorundrostat-treated participants achieved the AHA/ACC Guideline recommended office systolic blood pressure, or SBP, target of less than 130 mmHg. These results were presented at the American Heart Association Hypertension Scientific Sessions 2026, or AHA-HTN, taking place October 7-11 in Arlington, Virginia. In a separate oral presentation, the final results of the Phase 2 Explore-OSA trial of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension were featured. Participants receiving lorundrostat 50 mg once daily in the evening achieved clinically meaningful reductions in morning SBP of 11.1 mmHg at Week 4, compared with 1.0 mmHg reduction for participants receiving placebo, although no measurable change in apnea-hypopnea indices were observed with lorundrostat. In the study, lorundrostat exhibited a favorable safety and tolerability profile, and there was no evidence of significant safety events, including hyperkalemia.

Mineralys Reports $221.4M R&D Expenses for Q2

Research and development expenses for the quarter ended June 30 were $221.4M, compared to $38.3M for the quarter ended June 30, 2025. The increase in R&D expenses was primarily due to the $200M upfront payment to Tanabe in June in connection with the license agreement amendment. Net loss was $241.1M for the quarter ended June 30, compared to $43.3M for the quarter ended June 30, 2025. The increase was primarily attributable to the factors impacting the company's expenses described above. "I am very pleased to join the team at Mineralys in advance of the December PDUFA target date," said Terry Ferguson, Chief Medical Officer of Mineralys. "Uncontrolled or resistant hypertension is a major driver of cardiovascular morbidity and mortality and a continuing issue for millions of Americans. I look forward to helping bring new treatment options, like lorundrostat, to patients with hypertension and other conditions where modulating dysregulated aldosterone may provide significant benefit."

Mineralys Therapeutics Presents New Data on Lorundrostat Heart Failure Risk Biomarkers

Mineralys Therapeutics presented new data on the effect of lorundrostat on heart failure risk biomarkers. This post hoc analysis of circulating proteomic data from participants enrolled in the Company's Launch-HTN and Advance-HTN trials was presented in a late-breaking poster presentation at ENDO 2026, the Endocrine Society's annual meeting in Chicago, Illinois. "People with uncontrolled hypertension are at particular risk of heart failure, a condition where more effective treatments are still neededi," said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. "Aldosterone plays a well-established roleii in driving this disease, and these findings suggest that lorundrostat may act on the biological processes that contribute to heart failure, supporting further evaluation of its therapeutic potential in this setting."