---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-055242"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2025-06-02T23:59:59+00:00"
generated_at: "2026-05-20T02:54:09.099823+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# uniQure reaches FDA alignment on AMT-130 BLA for Huntington's disease; submission by Q1 2026

## Summary
- FDA supports cUHDRS as accelerated approval endpoint; primary analysis uses 3-year cUHDRS change vs propensity score-weighted ENROLL-HD external control.
- CMC validation: FDA agrees to use prior HEMGENIX knowledge, plus additional AMT-130 GMP batches and one PPQ batch; potency assay plan accepted pending qualification.
- BLA submission targeting Q1 2026 with request for priority review; pre-BLA meeting in Q4 2025; Phase I/II topline data in Q3 2025.
- Type B meetings held in Q1 and Q2 2025 on CMC and SAP; FDA aligned on statistical analysis plan including sensitivity analyses using TRACK-HD and PREDICT-HD datasets.

## SEC filing metadata
- accession: 0001104659-25-055242
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2025-06-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465925055242/0001104659-25-055242-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465925055242/tm2516829d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-055242
- JSON: https://secwatch.observer/filing/0001104659-25-055242.json
- Plain text: https://secwatch.observer/filing/0001104659-25-055242.txt

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