---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-104463"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-09-02T11:06:12+00:00"
generated_at: "2026-09-02T11:10:03.912466+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# uniQure submits BLA to FDA for AMT-130 in Huntington's disease; also files MAA in UK

## Summary
- Submitted BLA to FDA for accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington's disease.
- Also submitted MAA to UK MHRA for same therapy; both supported by 3-year Phase I/II data.
- Requested FDA priority review; if granted, review cycle shortened to 6 months after 60-day filing review.
- Plans to present 4-year data analysis from Phase I/II before end of Q3 2026.
- AMT-130 holds FDA Breakthrough Therapy, RMAT, and Fast Track designations.

## SEC filing metadata
- accession: 0001104659-26-104463
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-09-02T11:06:12+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/0001104659-26-104463-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/qure-20260902x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-104463
- JSON: https://secwatch.observer/filing/0001104659-26-104463.json
- Plain text: https://secwatch.observer/filing/0001104659-26-104463.txt

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