secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2026-04-30T23:59:59+00:00
Accession:  0001104659-26-052112
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure plans UK MAA submission for AMT-130 in Q3 2026 after successful MHRA meeting
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- Successful MHRA pre-submission meeting for AMT-130 gene therapy in Huntington's disease.
- Expected MAA submission in Q3 2026 based on Phase I/II three-year data showing 75% slowing of disease progression at high dose.
- FDA Type B meeting granted in Q2 2026 to discuss potential Phase III design and four-year analysis plan.
- Actively pursuing additional ex-US regulatory pathways for AMT-130; updates expected H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926052112/0001104659-26-052112-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926052112/qure-20260430x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-052112

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