---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-120915"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-11-02T12:15:22+00:00"
generated_at: "2026-11-02T12:20:09.234130+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts uniQure's Huntington's gene therapy BLA, grants Priority Review with PDUFA date May 1, 2027

## Summary
- FDA accepted for review the BLA for ifezuntirgene inilparvovec (AMT-130) under the Accelerated Approval pathway with Priority Review; PDUFA target action date May 1, 2027.
- In its acceptance letter, FDA said it is tentatively planning to discuss the application at an Advisory Committee meeting; date and timelines not yet finalized.
- Confirmatory study aligned with FDA: ~200 patients randomized 2:1 to ifezuntirgene inilparvovec vs standard of care, Total Functional Capacity primary endpoint at 36 months.
- BLA rests on 36-month Phase I/II data vs a propensity score-matched external control from the Enroll-HD database, disclosed Sept 24, 2025; 51 patients dosed in the program.
- First Huntington's therapy with Breakthrough Therapy and RMAT designations; also holds Fast Track. US confirmatory-trial screening planned by end of 2026.

## SEC filing metadata
- accession: 0001104659-26-120915
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-11-02T12:15:22+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465926120915/0001104659-26-120915-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926120915/tm2628699d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-120915
- JSON: https://secwatch.observer/filing/0001104659-26-120915.json
- Plain text: https://secwatch.observer/filing/0001104659-26-120915.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.