---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-111654"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-09-29T13:05:32+00:00"
generated_at: "2026-10-12T13:44:09.426476+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# uniQure reports AMT-130 Phase I/II data: 80% slowing of Huntington's progression at 36 months in high-dose patients

## Summary
- At 36 months, 15 high-dose patients showed 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (p=0.011) vs the updated ENROLL-HD external control.
- At 48 months (n=12 high dose), cUHDRS slowing was 44% (p=0.144, not significant) and TFC 61% (p=0.008); a post-hoc prior-control analysis showed 53.5% and 68.3%.
- FDA said 36-month data from 12 high-dose patients could support the accelerated-approval BLA, which was submitted before today's topline results were available.
- Five high-dose patients (17%) had treatment-related serious adverse events from CNS inflammation, all resolved; one low-dose patient suicide ~5 years post-treatment was assessed as unrelated.
- uniQure hosts an investor call today at 8:30 a.m. ET; AMT-130 holds FDA Breakthrough Therapy, RMAT and Fast Track designations.

## SEC filing metadata
- accession: 0001104659-26-111654
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-09-29T13:05:32+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465926111654/0001104659-26-111654-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926111654/tm2626514d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-111654
- JSON: https://secwatch.observer/filing/0001104659-26-111654.json
- Plain text: https://secwatch.observer/filing/0001104659-26-111654.txt

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