---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-108802"
form_type: "8-K"
ticker: "QURE"
cik: "0001590560"
company_name: "uniQure N.V."
filed_at: "2025-11-10T23:59:59+00:00"
generated_at: "2026-05-16T22:24:43.148405+00:00"
event_type: "earnings"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# uniQure Q3 net loss $80.5M; FDA creates uncertainty for AMT-130 BLA

## Summary
- Net loss of $80.5M ($1.38 loss per share) vs $44.4M loss in Q3 2024; revenue $3.7M (+$1.4M YoY).
- Cash, cash equivalents and investments $694.2M as of Sept 30, 2025; raised ~$323.7M net from public offering.
- AMT-130 Phase I/II topline: 75% slowing in cUHDRS (p=0.003), 60% in TFC (p=0.033) at 36 months vs external control.
- Pre-BLA meeting with FDA: FDA no longer agrees Phase I/II data vs external control may support BLA; submission timing unclear.
- R&D expenses $34.4M (+$3.8M YoY) driven by $6.6M in BLA preparation; SG&A $19.4M (+$7.8M YoY).

## SEC filing metadata
- accession: 0001104659-25-108802
- form_type: 8-K
- ticker: QURE
- cik: 0001590560
- company_name: uniQure N.V.
- filed_at: 2025-11-10T23:59:59+00:00
- event_type: earnings
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590560/000110465925108802/0001104659-25-108802-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590560/000110465925108802/qure-20251110x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-108802
- JSON: https://secwatch.observer/filing/0001104659-25-108802.json
- Plain text: https://secwatch.observer/filing/0001104659-25-108802.txt

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