secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2022-11-02T23:59:59+00:00
Accession:  0001104659-22-113966
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure Q3 net loss $47.9M; DSMB recommends resuming higher-dose AMT-130 enrollment
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- Net loss $47.9M ($1.02/share) vs $36.5M ($0.79) in Q3 2021; revenue $1.4M down from $2.0M.
- Cash $440.3M as of Sep 30, 2022; expected to fund operations into H1 2025.
- DSMB recommends resuming higher-dose AMT-130 enrollment in European Phase Ib/II after SUSARs resolved.
- BLA for etranacogene dezaparvovec under FDA priority review; EMA issued GMP certificate.
- IND-enabling studies initiated for AMT-260 (epilepsy) and AMT-191 (Fabry); submissions expected 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465922113966/0001104659-22-113966-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465922113966/tm2229521d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-113966

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