Mineralys Therapeutics presents Phase 3 data showing lorundrostat cuts blood pressure and albuminuria
Mineralys Therapeutics (MLYS) disclosed results from its pivotal Phase 3 Launch‑HTN trial at ASN Kidney Week. The aldosterone‑synthase inhibitor lorundrostat lowered systolic blood pressure by 9.6 mmHg in participants with chronic kidney disease and by 12.2 mmHg in those without CKD. In CKD patients with baseline albuminuria, the drug reduced urine albumin‑to‑creatinine ratio by 52 %. FDA review of the product is ongoing with a PDUFA decision expected on Dec 22 2026.
Why it matters
The company says the data demonstrate clinically meaningful efficacy in both blood pressure and kidney‑damage markers, supporting its regulatory filing and potential market launch. The upcoming PDUFA date will determine whether the drug can be commercialized, which could materially affect MLYS’s valuation.
Key facts
- 1Lorundrostat reduced placebo‑adjusted systolic blood pressure by 9.6 mmHg in participants with CKD (p=0.0022). stocktitan.net
- 2Lorundrostat reduced placebo‑adjusted systolic blood pressure by 12.2 mmHg in participants without CKD (p<0.0001). stocktitan.net
- 3In CKD patients with baseline albuminuria, lorundrostat lowered urine albumin‑to‑creatinine ratio by 52 %. stocktitan.net
- 4The FDA’s PDUFA decision date for lorundrostat is set for Dec 22 2026. tradingview.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.