secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2025-09-24T23:59:59+00:00
Accession:  0001104659-25-092740
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure AMT-130 Phase I/II meets primary endpoint: 75% HD progression slowing at 36 months
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- High-dose AMT-130 showed 75% slowing on cUHDRS (p=0.003) vs external control; key secondary TFC endpoint also met (60% slowing, p=0.033).
- Mean CSF NfL reduced 8.2% from baseline at 36 months, supporting potential disease modification.
- No new drug-related serious adverse events since Dec 2022; manageable safety profile.
- Company plans pre-BLA meeting with FDA later 2025, BLA submission targeted for Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465925092740/0001104659-25-092740-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465925092740/qure-20250924x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-092740

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