secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2023-12-19T23:59:59+00:00
Accession:  0001104659-23-127117
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure AMT-130 shows dose-dependent clinical benefit in Huntington's; NfL below baseline at 30 months
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- AMT-130 showed favorable cUHDRS difference of 0.39 (low-dose at 30 months) and 1.24 (high-dose at 18 months) vs natural history.
- Mean CSF NfL low-dose cohort 6.6% below baseline at 30 months; high-dose cohort near baseline at 18 months.
- AMT-130 generally well-tolerated; 4 AMT-130-related SAEs (CNS inflammation) in high-dose cohort managed with steroids.
- Company plans regulatory interactions in Q1 2024 and next clinical update mid-2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465923127117/0001104659-23-127117-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465923127117/tm2333072d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-127117

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