secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2025-11-10T23:59:59+00:00
Accession:  0001104659-25-108802
Event type: earnings
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465925108802/0001104659-25-108802-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465925108802/qure-20251110x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-108802

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer