---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-092740"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2025-09-24T23:59:59+00:00"
generated_at: "2026-05-17T05:46:25.794799+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# uniQure AMT-130 Phase I/II meets primary endpoint: 75% HD progression slowing at 36 months

## Summary
- High-dose AMT-130 showed 75% slowing on cUHDRS (p=0.003) vs external control; key secondary TFC endpoint also met (60% slowing, p=0.033).
- Mean CSF NfL reduced 8.2% from baseline at 36 months, supporting potential disease modification.
- No new drug-related serious adverse events since Dec 2022; manageable safety profile.
- Company plans pre-BLA meeting with FDA later 2025, BLA submission targeted for Q1 2026.

## SEC filing metadata
- accession: 0001104659-25-092740
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2025-09-24T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465925092740/0001104659-25-092740-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465925092740/qure-20250924x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-092740
- JSON: https://secwatch.observer/filing/0001104659-25-092740.json
- Plain text: https://secwatch.observer/filing/0001104659-25-092740.txt

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