---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-052112"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-04-30T23:59:59+00:00"
generated_at: "2026-05-15T00:56:32.271424+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# uniQure plans UK MAA submission for AMT-130 in Q3 2026 after successful MHRA meeting

## Summary
- Successful MHRA pre-submission meeting for AMT-130 gene therapy in Huntington's disease.
- Expected MAA submission in Q3 2026 based on Phase I/II three-year data showing 75% slowing of disease progression at high dose.
- FDA Type B meeting granted in Q2 2026 to discuss potential Phase III design and four-year analysis plan.
- Actively pursuing additional ex-US regulatory pathways for AMT-130; updates expected H2 2026.

## SEC filing metadata
- accession: 0001104659-26-052112
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-04-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1590560/000110465926052112/0001104659-26-052112-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926052112/qure-20260430x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-052112
- JSON: https://secwatch.observer/filing/0001104659-26-052112.json
- Plain text: https://secwatch.observer/filing/0001104659-26-052112.txt

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