{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-104463","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2026-09-02T11:06:12+00:00","discovered_at":"2026-09-02T11:10:00.540672+00:00","generated_at":"2026-09-02T11:10:03.912466+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"uniQure submits BLA to FDA for AMT-130 in Huntington's disease; also files MAA in UK","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-104463","json":"https://secwatch.observer/filing/0001104659-26-104463.json","markdown":"https://secwatch.observer/filing/0001104659-26-104463.md","text":"https://secwatch.observer/filing/0001104659-26-104463.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/0001104659-26-104463-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/qure-20260902x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-02T11:10:03.912466+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"}