---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-118292"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2025-12-04T23:59:59+00:00"
generated_at: "2026-05-16T14:41:20.524122+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA says uniQure's AMT-130 Phase I/II data unlikely to support BLA submission

## Summary
- FDA final meeting minutes from Oct 29 pre-BLA meeting: Phase I/II data for AMT-130 unlikely to support BLA submission.
- uniQure plans to request follow-up FDA meeting in Q1 2026 to discuss path forward.
- AMT-130 targets Huntington's disease; company evaluating FDA feedback.
- CEO Matt Kapusta reaffirms commitment to advancing AMT-130.

## SEC filing metadata
- accession: 0001104659-25-118292
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2025-12-04T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465925118292/0001104659-25-118292-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465925118292/qure-20251204x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-118292
- JSON: https://secwatch.observer/filing/0001104659-25-118292.json
- Plain text: https://secwatch.observer/filing/0001104659-25-118292.txt

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