---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-008845"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2024-06-03T23:59:59+00:00"
generated_at: "2026-06-01T06:48:31.745759+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# uniQure receives FDA RMAT designation for gene therapy AMT-130 in Huntington's disease

## Summary
- FDA granted RMAT designation for AMT-130 based on 24-month Phase I/II data vs. natural history cohort.
- First RMAT designation ever for a Huntington's disease therapy, enabling fast track and breakthrough therapy benefits.
- Designation allows increased collaboration with FDA on accelerated approval pathways and expedited development.
- uniQure expects to provide updated interim data from Phase I/II studies in mid-2024, including up to 3-year follow-up on 29 patients.

## SEC filing metadata
- accession: 0001558370-24-008845
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2024-06-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000155837024008845/0001558370-24-008845-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000155837024008845/qure-20240603x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-008845
- JSON: https://secwatch.observer/filing/0001558370-24-008845.json
- Plain text: https://secwatch.observer/filing/0001558370-24-008845.txt

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