# Lorundrostat PDUFA Event: Hypertension

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MLYS/lorundrostat-hypertension

Ticker: MLYS

Company: Mineralys Therapeutics

Event date: 2026-12-22

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a December 22, 2026 PDUFA target action date to the lorundrostat NDA.

## Event Timeline

### December 22, 2026 — FDA decision expected

FDA assigned a December 22, 2026 PDUFA target action date to the lorundrostat NDA.

[Mineralys — NDA acceptance and PDUFA date](https://ir.mineralystx.com/news-events/press-releases/detail/93/mineralys-therapeutics-announces-fda-acceptance-of-nda-for)

### March 9, 2026 — FDA acceptance of the NDA was announced

FDA accepted the application for lorundrostat in combination with other antihypertensive drugs for adults with hypertension.

[Mineralys — NDA acceptance](https://ir.mineralystx.com/news-events/press-releases/detail/93/mineralys-therapeutics-announces-fda-acceptance-of-nda-for)

### December 22, 2025 — Mineralys submitted the NDA

The application was supported by a clinical program including the pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials.

[Mineralys — Annual report and NDA submission](https://ir.mineralystx.com/sec-filings/all-sec-filings/content/0001933414-26-000056/mlys-20251231.htm)

### March 10, 2025 — Launch-HTN and Advance-HTN met their primary endpoints

Both pivotal trials showed statistically significant and clinically meaningful blood-pressure reductions with a favorable safety and tolerability profile.

[Mineralys — Positive pivotal trial topline results](https://ir.mineralystx.com/news-events/press-releases/detail/60/mineralys-therapeutics-announces-positive-topline-results)

### November 22, 2023 — Phase 3 Launch-HTN started

The Phase 3 study began evaluating lorundrostat in adults with uncontrolled or resistant hypertension receiving background antihypertensive therapy.

[ClinicalTrials.gov — Launch-HTN study record](https://clinicaltrials.gov/study/NCT06153693)

### March 13, 2023 — Pivotal Advance-HTN started

The randomized pivotal Phase 2 study began evaluating lorundrostat as add-on therapy for uncontrolled or resistant hypertension.

[ClinicalTrials.gov — Advance-HTN study record](https://clinicaltrials.gov/study/NCT05769608)

## Related Pages

- MLYS PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/MLYS.md

- MLYS company profile: https://biopharmsignal.com/company/MLYS.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-09-09 — Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/MLYS/mineralys-therapeutics-reports-inducement-awards-under-nasdaq-listing-rule-5635--d66eb8dc.md

- 2026-08-26 — Mineralys Therapeutics to Participate in the Wells Fargo 21st Annual Healthcare Conference: https://biopharmsignal.com/news/MLYS/mineralys-therapeutics-to-participate-in-the-wells-fargo-21st-annual-healthcare--a7db500f.md

- 2026-08-13 — Mineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/MLYS/mineralys-therapeutics-reports-inducement-award-under-nasdaq-listing-rule-5635-c-b688cecf.md

- 2026-08-11 — Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update: https://biopharmsignal.com/news/MLYS/mineralys-therapeutics-reports-second-quarter-2026-financial-results-and-provide-bde4064d.md

- 2026-08-04 — Mineralys Therapeutics to Announce Second Quarter 2026 Financial Results and Host Conference Call on Tuesday, August 11, 2026: https://biopharmsignal.com/news/MLYS/mineralys-therapeutics-to-announce-second-quarter-2026-financial-results-and-hos-3e424d6c.md