Lorundrostat Cuts Albuminuria 52% in CKD as FDA Decision Nears
MLYS is trading near its 52-week low of $20.12 (6.7% above the low).
Summary
Mineralys disclosed Phase 3 Launch-HTN subgroup data for lorundrostat: placebo-adjusted systolic blood pressure fell 9.6 mmHg in CKD patients (p=0.0022) and 12.2 mmHg in non-CKD patients (p<0.0001) at week 12. The CKD arm also showed a 52.2% reduction in UACR versus placebo, a renal risk marker that could support differentiated label language, with hyperkalemia at 2.4% in CKD. This builds on the top-line Launch-HTN results reported October 9 and arrives while the FDA reviews lorundrostat for hypertension, with a PDUFA date of December 22, 2026. The company held $661.4M in cash as of the August 10-Q, so funding the launch is not the near-term issue — the label is. Watch the December 22 PDUFA decision and whether the label explicitly covers CKD and albuminuria.
At the time of this announcement, MLYS was trading at $21.47 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.