secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2024-07-09T23:59:59+00:00
Accession:  0001558370-24-009696
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure announces positive interim Phase I/II data for AMT-130: 80% slowing of Huntington's progression at high dose
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- High-dose AMT-130 showed 80% slowing of cUHDRS decline vs. external control at 24 months (p=0.007).
- CSF neurofilament light chain reduced 11% from baseline at 24 months in treated patients (p=0.02).
- AMT-130 received first-ever RMAT designation for Huntington's disease from FDA.
- Company expects to meet with FDA in H2 2024 to discuss expedited development and accelerated approval.
- No new AMT-130-related serious adverse events; safety profile manageable at both doses.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000155837024009696/0001558370-24-009696-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000155837024009696/qure-20240709x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-24-009696

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