---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-016106"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2024-12-10T23:59:59+00:00"
generated_at: "2026-05-29T05:10:45.614585+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# uniQure reaches FDA alignment on Accelerated Approval pathway for AMT-130 in Huntington's disease

## Summary
- FDA agrees data from ongoing Phase I/II studies vs natural history external control may serve as primary basis for BLA under Accelerated Approval.
- FDA agrees cUHDRS may serve as intermediate clinical endpoint; reductions in CSF NfL provide supportive evidence of benefit.
- Company initiated BLA readiness activities; plans to discuss statistical analysis plan and CMC requirements with FDA in H1 2025.

## SEC filing metadata
- accession: 0001558370-24-016106
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2024-12-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000155837024016106/0001558370-24-016106-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000155837024016106/qure-20241210x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-016106
- JSON: https://secwatch.observer/filing/0001558370-24-016106.json
- Plain text: https://secwatch.observer/filing/0001558370-24-016106.txt

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