{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-118292","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2025-12-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.845781+00:00","generated_at":"2026-05-16T14:41:20.524122+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA says uniQure's AMT-130 Phase I/II data unlikely to support BLA submission","bullets":["FDA final meeting minutes from Oct 29 pre-BLA meeting: Phase I/II data for AMT-130 unlikely to support BLA submission.","uniQure plans to request follow-up FDA meeting in Q1 2026 to discuss path forward.","AMT-130 targets Huntington's disease; company evaluating FDA feedback.","CEO Matt Kapusta reaffirms commitment to advancing AMT-130."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-118292","json":"https://secwatch.observer/filing/0001104659-25-118292.json","markdown":"https://secwatch.observer/filing/0001104659-25-118292.md","text":"https://secwatch.observer/filing/0001104659-25-118292.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925118292/0001104659-25-118292-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925118292/qure-20251204x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:41:20.524122+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}