secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2025-05-09T23:59:59+00:00
Accession:  0001558370-25-007065
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure Q1 net loss per share $0.82; AMT-130 granted FDA Breakthrough Therapy designation
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- Net loss $43.6M ($0.82 per share) vs $65.6M ($1.36) in Q1 2024; revenue down to $1.6M from $8.5M.
- Cash and investments $409M as of Mar 31, 2025; expects funding into H2 2027.
- AMT-130 for Huntington's disease granted FDA Breakthrough Therapy designation in Apr 2025.
- BLA submission guidance for AMT-130 expected in Q2 2025 after official meeting minutes.
- Initial AMT-260 epilepsy data to be presented May 29, 2025; AMT-191 Fabry data in H2 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000155837025007065/0001558370-25-007065-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000155837025007065/qure-20250509x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-007065

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