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The data show robust SBP reductions and meaningful UACR improvements in CKD, with favorable safety; FDA NDA clock started with a clear Dec 2026 target, elevating near-term sentiment and potential re-rating if data remain compelling or if FDA interactions are positive.
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Mineralys reported post hoc Launch-HTN results showing lorundrostat delivered meaningful blood pressure reductions and reduced albuminuria in CKD patients, with a favorable safety profile. CKD and non-CKD groups achieved SBP improvements, with 44% of CKD patients reaching SBP <130 mmHg versus 18% placebo, and a 52.2% UACR reduction in CKD with albuminuria. NDA review remains on track for December 2026, supporting a potential near-term regulatory catalyst.
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