MIRM

Zilurgisertib

FDA PDUFA Target Action Date · Mirum Pharmaceuticals, Inc.

Saturday, September 26, 2026

6 days away

Note: Oral ALK2 inhibitor licensed by Mirum from Incyte (Apr 2026). NDA based on pivotal Phase 2 PROGRESS study (Cohort 1, patients 12+). FDA granted Priority Review; PDUFA target action date September 26, 2026 (confirmed in Mirum/Incyte company release).

Drug Information

Drug Name: Zilurgisertib (CT.gov)
Application Type: NDA
FDA Designations: Priority Review
Indication: Fibrodysplasia ossificans progressiva (FOP), patients 12 years and older

Filing Details

Company: Mirum Pharmaceuticals, Inc. →
Stock Ticker: MIRM
SEC CIK
Source: company press release →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

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Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue