{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-120915","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2026-11-02T12:15:22+00:00","discovered_at":"2026-11-02T12:20:00.290933+00:00","generated_at":"2026-11-02T12:20:09.234130+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts uniQure's Huntington's gene therapy BLA, grants Priority Review with PDUFA date May 1, 2027","bullets":["FDA accepted for review the BLA for ifezuntirgene inilparvovec (AMT-130) under the Accelerated Approval pathway with Priority Review; PDUFA target action date May 1, 2027.","In its acceptance letter, FDA said it is tentatively planning to discuss the application at an Advisory Committee meeting; date and timelines not yet finalized.","Confirmatory study aligned with FDA: ~200 patients randomized 2:1 to ifezuntirgene inilparvovec vs standard of care, Total Functional Capacity primary endpoint at 36 months.","BLA rests on 36-month Phase I/II data vs a propensity score-matched external control from the Enroll-HD database, disclosed Sept 24, 2025; 51 patients dosed in the program.","First Huntington's therapy with Breakthrough Therapy and RMAT designations; also holds Fast Track. US confirmatory-trial screening planned by end of 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-120915","json":"https://secwatch.observer/filing/0001104659-26-120915.json","markdown":"https://secwatch.observer/filing/0001104659-26-120915.md","text":"https://secwatch.observer/filing/0001104659-26-120915.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926120915/0001104659-26-120915-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926120915/tm2628699d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-02T12:20:09.234130+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"}