Mineralys Therapeutics, Inc. MLYS
Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is a cardio-renal-metabolic drug developer. Its lead program, Lorundrostat, is in Phase 3 for Hypertension (uncontrolled and resistant) with and without CKD.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Lorundrostat | Uncontrolled / resistant hypertension | small molecule | Phase 3 |
| Lorundrostat | Chronic kidney disease with hypertension; other cardio-renal indications | small molecule | Phase 2 |
Recent results and decisions
- Mar 9, 2026accepted FDA accepted the lorundrostat NDA for adults with hypertension in combination with other antihypertensives; PDUFA target action date December 22, 2026.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.
Filing - Mar 9, 2026missed Explore-OSA (n=48) missed primary endpoint of AHI change vs placebo; BP fell 11.1 mmHg vs 1.0 mmHg on placebo in parallel-arm analysis, 6.2 mmHg placebo-adjusted in crossover (p<0.0003); well tolerated.
After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index (AHI), the primary endpoint.
Filing - Jan 6, 2026submitted Mineralys states it filed the lorundrostat NDA with the FDA in late 2025.
Mineralys filed an NDA for lorundrostat to the U.S. Food and Drug Administration (FDA) in late 2025.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.