secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2026-09-29T13:05:32+00:00
Accession:  0001104659-26-111654
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

uniQure reports AMT-130 Phase I/II data: 80% slowing of Huntington's progression at 36 months in high-dose patients
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- At 36 months, 15 high-dose patients showed 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (p=0.011) vs the updated ENROLL-HD external control.
- At 48 months (n=12 high dose), cUHDRS slowing was 44% (p=0.144, not significant) and TFC 61% (p=0.008); a post-hoc prior-control analysis showed 53.5% and 68.3%.
- FDA said 36-month data from 12 high-dose patients could support the accelerated-approval BLA, which was submitted before today's topline results were available.
- Five high-dose patients (17%) had treatment-related serious adverse events from CNS inflammation, all resolved; one low-dose patient suicide ~5 years post-treatment was assessed as unrelated.
- uniQure hosts an investor call today at 8:30 a.m. ET; AMT-130 holds FDA Breakthrough Therapy, RMAT and Fast Track designations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926111654/0001104659-26-111654-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926111654/tm2626514d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-111654

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