FDA accepts Mineralys' NDA for hypertension drug lorundrostat; PDUFA Dec 22, 2026

Mineralys Therapeutics, Inc.

FDA accepted NDA for lorundrostat for hypertension in combination with other antihypertensives; PDUFA target date December 22, 2026.
Phase 2 Explore-OSA trial did not meet primary endpoint; lorundrostat did not reduce apnea-hypopnea index vs placebo.
Lorundrostat showed 11.1 mmHg BP reduction vs 1.0 mmHg for placebo (p<0.0001) at week 4; placebo-adjusted reduction 6.2 mmHg (p<0.0003).
Safety favorable: no serum potassium >5.5 mmol/L; analysis ongoing for other endpoints.
Company believes lorundrostat has potential for resistant/uncontrolled hypertension; topline data from Explore-OSA reported.

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