secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2025-07-29T23:59:59+00:00
Accession:  0001558370-25-009692
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure reports Q2 loss of $37.7M; FDA agrees on AMT-130 BLA pathway for Q1 2026 submission
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- Revenue $5.3M, down from $11.1M YoY; net loss $37.7M ($0.69/share).
- FDA alignment on SAP and CMC for AMT-130 BLA; topline three-year data in Sept 2025.
- AMT-260 first patient showed 92% seizure reduction at 5 months with no serious AEs.
- Cash $377M expected to fund operations into H2 2027.
- Appointed Kylie O’Keefe as Chief Customer and Strategy Officer.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000155837025009692/0001558370-25-009692-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000155837025009692/qure-20250729x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-009692

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