Lorundrostat Cuts BP 7.5 mmHg and Proteinuria in Phase 2 CKD Trial
MLYS is trading near its 52-week low of $20.12 (5.9% above the low) on elevated volume (2.7× avg).
Summary
Mineralys' Phase 2 Explore-CKD study met its primary endpoint: lorundrostat 25 mg lowered systolic blood pressure by 7.5 mmHg versus placebo at four weeks in chronic kidney disease patients already on ACE/ARB and SGLT2 therapy. The drug also cut albuminuria (UACR) by 25.6% and 24-hour urine protein by 22.1% versus placebo, with serum aldosterone down 41.5% — evidence of an on-target hormonal effect and a possible renal benefit beyond blood pressure. Safety was consistent with prior trials, so no new risk signal emerged. The caveat is size: n=59 in a short 2x2 crossover design, which limits how much this reads through to registrational data. This adds CKD evidence to the Phase 3 Launch-HTN hypertension dataset reported earlier this month, broadening the lorundrostat story ahead of the December 2026 FDA decision on the NDA.
At the time of this announcement, MLYS was trading at $21.30 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.9B. The 52-week trading range was $20.12 to $47.65. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.