secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2026-09-02T11:06:12+00:00
Accession:  0001104659-26-104463
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure submits BLA to FDA for AMT-130 in Huntington's disease; also files MAA in UK
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- Submitted BLA to FDA for accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington's disease.
- Also submitted MAA to UK MHRA for same therapy; both supported by 3-year Phase I/II data.
- Requested FDA priority review; if granted, review cycle shortened to 6 months after 60-day filing review.
- Plans to present 4-year data analysis from Phase I/II before end of Q3 2026.
- AMT-130 holds FDA Breakthrough Therapy, RMAT, and Fast Track designations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/0001104659-26-104463-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/qure-20260902x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-104463

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