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/resistant). Its next catalyst on record is Lorundrostat: FDA PDUFA action date for NDA (December 2026).
Upcoming catalysts
- December 2026Lorundrostat — FDA PDUFA action date for NDA
FDA accepted the NDA with a PDUFA target action date of December 22, 2026.
- December 2026lorundrostat (hypertension) — FDA PDUFA decision on NDA
The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| lorundrostat | hypertension (uncontrolled/resistant) | small molecule | Phase 3 |
| lorundrostat | hypertension with chronic kidney disease (CKD) | small molecule | Phase 2 |
| lorundrostat | obstructive sleep apnea (OSA) with hypertension | small molecule | Phase 2 |
Recent results and decisions
- Nov 4, 2026accepted FDA continues review of lorundrostat NDA for hypertension with PDUFA target date of December 22, 2026.
The U.S. Food and Drug Administration (FDA) continues its review of the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.
Filing - Nov 4, 2026positive New Launch-HTN analysis showed 46% of participants receiving lorundrostat 50 mg achieved AHA/ACC guideline SBP target of <130 mmHg at Week 12.
A new analysis of the pivotal Phase 3 Launch-HTN trial showed that at Week 12, 46% of lorundrostat-treated participants (50 mg) achieved the AHA/ACC guideline-recommended office systolic blood pressure (SBP) target of <130 mmHg.
Filing - 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
3 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.