Mineralys Therapeutics Says FDA Accepts NDA For Lorundrostat For Treatment Of Adult Patients With Hypertension In Combination With Other Antihypertensive Drugs; PDUFA Target Action Date December 22

– The FDA assigned a PDUFA target action date of December 22, 2026 –

– The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension –

– Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension –

RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.