# Zilurgisertib PDUFA Event: Fibrodysplasia ossificans progressiva

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MIRM/zilurgisertib-fibrodysplasia-ossificans-progressiva

Ticker: MIRM

Company: Mirum Pharmaceuticals

Event date: 2026-09-26

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a September 26, 2026 PDUFA target action date to the zilurgisertib NDA.

## Event Timeline

### September 26, 2026 — FDA decision expected

FDA assigned a September 26, 2026 PDUFA target action date to the zilurgisertib NDA.

[Mirum — NDA acceptance, Priority Review and PDUFA date](https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx)

### June 14, 2026 — Pivotal PROGRESS results were presented

The pivotal Phase 2 study reported reductions in heterotopic-ossification lesion measures and flare activity in adolescents and adults with FOP, with no adverse events leading to discontinuation or dose reduction.

[Mirum and Incyte — Positive pivotal PROGRESS results](https://investor.incyte.com/news-releases/news-release-details/mirum-pharmaceuticals-and-incyte-announce-positive-pivotal-phase)

### May 6, 2026 — Mirum disclosed the accepted NDA and licensed the program

Mirum obtained exclusive worldwide rights to zilurgisertib from Incyte and confirmed that FDA had accepted the NDA with Priority Review for patients age 12 and older.

[Mirum — Zilurgisertib license and regulatory update](https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx)

### May 5, 2022 — Phase 2 PROGRESS study started

PROGRESS began evaluating zilurgisertib in adults with fibrodysplasia ossificans progressiva and later supplied the pivotal efficacy and safety dataset for the NDA.

[ClinicalTrials.gov — PROGRESS study record (NCT05090891)](https://clinicaltrials.gov/study/NCT05090891)

## Regulatory Designations

- Priority Review FDA: [Mirum — NDA acceptance, Priority Review and PDUFA date](https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update/default.aspx)

## Related Pages

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

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

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