MLYS Mineralys

Mineralys: FDA sets lorundrostat PDUFA date for December 22, 2026

The FDA has set a PDUFA target action date of December 22, 2026 for the NDA of lorundrostat for hypertension. The company is advancing commercial launch preparations ahead of this date and remains on track.

Mineralys presents Launch-HTN CKD data at ESH 2026

Post-hoc analysis of the Phase 3 Launch-HTN trial shows lorundrostat 50 mg produced statistically significant, placebo-adjusted SBP reductions of 9.6 mmHg in CKD participants and 12.2 mmHg in non-CKD participants at week 12. In CKD patients with baseline albuminuria, lorundrostat also reduced UACR by 52.2% placebo-adjusted, with a favorable safety profile in both groups.

Mineralys: FDA accepts lorundrostat NDA, sets Dec 22 2026 PDUFA

FDA accepted the lorundrostat NDA for hypertension and assigned a PDUFA target action date of December 22, 2026. The acceptance moves the asset into active regulatory review with a defined decision deadline. Pre-commercial launch activities are now underway ahead of the target date.

Mineralys: FDA accepts lorundrostat NDA, sets PDUFA date Dec 22, 2026

FDA accepted the NDA for lorundrostat in hypertension and assigned a PDUFA target action date of December 22, 2026. The acceptance follows five positive clinical trials and moves the asset into formal FDA review. No additional regulatory milestones are stated in the document.

Mineralys: FDA accepts NDA for lorundrostat; PDUFA set for Dec 22 2026

FDA accepted the NDA for lorundrostat in hypertension and assigned a PDUFA target action date of December 22, 2026. The NDA is supported by positive Phase 3 Launch-HTN and Phase 2 Advance-HTN data showing clinically meaningful blood-pressure reductions. The Phase 2 Explore-OSA trial missed its primary AHI endpoint but confirmed a 6.2 mmHg placebo-adjusted BP reduction and favorable safety.

Mineralys: Explore-OSA Phase 2 topline readout expected Q1 2026

The company announced it remains on track to report topline results from the Phase 2 Explore-OSA trial in Q1 2026. The trial evaluates lorundrostat's effects on OSA symptoms and blood pressure in patients with hypertension and moderate to severe OSA. This readout will provide additional data supporting lorundrostat's profile in hypertension with comorbid conditions.

Mineralys plans NDA submission for lorundrostat in late-2025/Q1 2026

The company announced plans to submit an NDA for lorundrostat in late-2025 or Q1 2026 following pre-NDA FDA feedback. Enrollment is complete in the Explore-OSA Phase 2 trial with topline data expected in Q1 2026. The NDA will be supported by data from multiple trials including the pivotal Launch-HTN and Advance-HTN studies.