Mineralys reports positive phase 2 CKD trial results

Mineralys Therapeutics reported that its Phase 2 Explore-CKD trial met the primary endpoint, with lorundrostat 25 mg reducing systolic blood pressure by 7.5 mmHg vs. placebo at 4 weeks. The treatment also showed reductions in UACR and urine protein, along with a drop in serum aldosterone. The company aims for further trials to confirm sustained benefits and FDA review.

Mineralys Therapeutics (MLYS) reported that its Phase 2 Explore-CKD trial met its primary endpoint, showing a 7.5 mmHg reduction in systolic blood pressure for lorundrostat 25 mg once daily vs. placebo at four weeks. The trial involved 59 participants with uncontrolled hypertension, CKD, and albuminuria. Lorundrostat also reduced urinary protein loss and serum aldosterone levels. The company plans further evaluation of the drug's potential benefits for these conditions.

Mineralys Therapeutics (MLYS) reported Phase 3 data showing lorundrostat reduced systolic blood pressure and albuminuria in CKD patients. FDA review is ongoing with a PDUFA date of Dec 22, 2026.

Mineralys Therapeutics (MLYS) presented Phase 3 trial data showing lorundrostat reduced systolic blood pressure and urine protein in CKD patients. The drug cut SBP by 9.6 mmHg in CKD patients and 12.2 mmHg in others, with a 52% reduction in urine protein. The company aims to target hypertension and related comorbidities.

H.C. Wainwright reiterated a Buy rating and $56.00 price target for Mineralys Therapeutics (NASDAQ:MLYS), citing new clinical data for lorundrostat. The target implies 140% upside from the current stock price of $23.37. The firm highlights the drug's potential in treating difficult-to-treat hypertension ahead of a December 2026 PDUFA date. Mineralys reported a wider-than-expected Q2 2026 loss of $2.85 per share. UBS initiated coverage with a Neutral rating and $29.00 price target.

Mineralys Therapeutics (MLYS) reported Phase 3 data showing 46% of patients on lorundrostat 50 mg achieved SBP <130 mmHg at 12 weeks, with 70% seeing ≥10 mmHg reduction. Phase 2 data showed an 11.1 mmHg morning SBP drop at Week 4. The company aims for FDA approval and clear labeling for BP reduction in resistant hypertension.