secwatch.observer — SEC 8-K summary
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Issuer:     uniQure N.V. (QURE)
CIK:        0001590560
Form:       8-K
Filed at:   2026-03-02T23:59:59+00:00
Accession:  0001104659-26-021890
Event type: regulatory
Sentiment:  negative
Materiality: 1.00
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA rejects AMT-130 Phase I/II data as sufficient for approval; recommends randomized sham-controlled study
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- Net loss of $199.0M for 2025 vs $239.6M in 2024; revenue $16.1M down 41% YoY.
- Cash and investments $622.5M, expected to fund operations into H2 2029.
- FDA stated Phase I/II data vs external control insufficient for marketing application; strongly recommends prospective, randomized, double-blind, sham surgery-controlled study.
- Company plans to request Type B meeting in Q2 2026 to discuss Phase III study design.
- AMT-260 MTLE Phase I/IIa enrollment completed in first cohort; data expected H1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926021890/0001104659-26-021890-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590560/000110465926021890/qure-20260302x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-021890

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