---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-105223"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2025-11-03T23:59:59+00:00"
generated_at: "2026-05-17T00:52:45.596914+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA no longer considers AMT-130 Phase I/II vs external control adequate for BLA

## Summary
- Pre-BLA meeting feedback: FDA believes data from Phase I/II of AMT-130 vs external control may not serve as primary evidence for BLA.
- This reverses prior FDA guidance from multiple Type B meetings over past year and Breakthrough Therapy designation in April 2025.
- BLA submission timing for AMT-130 in Huntington's disease is now unclear.
- Company expects final meeting minutes within 30 days and plans to urgently engage FDA.
- uniQure also plans to pursue parallel discussions with EU and UK regulators.

## SEC filing metadata
- accession: 0001104659-25-105223
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2025-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465925105223/0001104659-25-105223-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465925105223/qure-20251103x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-105223
- JSON: https://secwatch.observer/filing/0001104659-25-105223.json
- Plain text: https://secwatch.observer/filing/0001104659-25-105223.txt

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