---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-074853"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-06-17T11:10:30+00:00"
generated_at: "2026-06-17T11:15:15.542574+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# uniQure to submit BLA for AMT-130 in Huntington's disease in Q3 2026 after FDA Type B meeting

## Summary
- FDA agreed 3-year Phase I/II analysis can serve as primary basis for accelerated approval BLA for AMT-130.
- Company plans BLA submission in Q3 2026; FDA seeks alignment on confirmatory study with standard-of-care control.
- AMT-130 has RMAT, Breakthrough Therapy, and Fast Track designations from FDA.
- 3-year data from 26 US and 13 EU patients compared against propensity-matched external control Enroll-HD dataset.

## SEC filing metadata
- accession: 0001104659-26-074853
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-06-17T11:10:30+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465926074853/0001104659-26-074853-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926074853/tm2618105d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-074853
- JSON: https://secwatch.observer/filing/0001104659-26-074853.json
- Plain text: https://secwatch.observer/filing/0001104659-26-074853.txt

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