---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-002317"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-01-09T23:59:59+00:00"
generated_at: "2026-05-16T11:03:40.480042+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# uniQure schedules Type A FDA meeting for accelerated approval of AMT-130 in Huntington's disease

## Summary
- Type A meeting with FDA scheduled to discuss BLA data package for accelerated approval of AMT-130 (Huntington's disease gene therapy).
- CEO Matt Kapusta emphasized commitment to constructive dialogue and timely resolution for patients with high unmet need.
- Regulatory update expected after receipt of official meeting minutes from the FDA.

## SEC filing metadata
- accession: 0001104659-26-002317
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-01-09T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465926002317/0001104659-26-002317-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926002317/qure-20260109x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-002317
- JSON: https://secwatch.observer/filing/0001104659-26-002317.json
- Plain text: https://secwatch.observer/filing/0001104659-26-002317.txt

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