---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-021890"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2026-03-02T23:59:59+00:00"
generated_at: "2026-05-15T22:39:25.726769+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# FDA rejects AMT-130 Phase I/II data as sufficient for approval; recommends randomized sham-controlled study

## Summary
- Net loss of $199.0M for 2025 vs $239.6M in 2024; revenue $16.1M down 41% YoY.
- Cash and investments $622.5M, expected to fund operations into H2 2029.
- FDA stated Phase I/II data vs external control insufficient for marketing application; strongly recommends prospective, randomized, double-blind, sham surgery-controlled study.
- Company plans to request Type B meeting in Q2 2026 to discuss Phase III study design.
- AMT-260 MTLE Phase I/IIa enrollment completed in first cohort; data expected H1 2026.

## SEC filing metadata
- accession: 0001104659-26-021890
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2026-03-02T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465926021890/0001104659-26-021890-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465926021890/qure-20260302x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-021890
- JSON: https://secwatch.observer/filing/0001104659-26-021890.json
- Plain text: https://secwatch.observer/filing/0001104659-26-021890.txt

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