secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2026-06-17T11:10:30+00:00
Accession:  0001104659-26-074853
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

uniQure to submit BLA for AMT-130 in Huntington's disease in Q3 2026 after FDA Type B meeting
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- FDA agreed 3-year Phase I/II analysis can serve as primary basis for accelerated approval BLA for AMT-130.
- Company plans BLA submission in Q3 2026; FDA seeks alignment on confirmatory study with standard-of-care control.
- AMT-130 has RMAT, Breakthrough Therapy, and Fast Track designations from FDA.
- 3-year data from 26 US and 13 EU patients compared against propensity-matched external control Enroll-HD dataset.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926074853/0001104659-26-074853-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926074853/tm2618105d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-074853

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