{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-074853","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2026-06-17T11:10:30+00:00","discovered_at":"2026-06-17T11:15:00.355059+00:00","generated_at":"2026-06-17T11:15:15.542574+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"uniQure to submit BLA for AMT-130 in Huntington's disease in Q3 2026 after FDA Type B meeting","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-074853","json":"https://secwatch.observer/filing/0001104659-26-074853.json","markdown":"https://secwatch.observer/filing/0001104659-26-074853.md","text":"https://secwatch.observer/filing/0001104659-26-074853.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926074853/0001104659-26-074853-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926074853/tm2618105d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T11:15:15.542574+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"}