{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-055242","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2025-06-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.917632+00:00","generated_at":"2026-05-20T02:54:09.099823+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"uniQure reaches FDA alignment on AMT-130 BLA for Huntington's disease; submission by Q1 2026","bullets":["FDA supports cUHDRS as accelerated approval endpoint; primary analysis uses 3-year cUHDRS change vs propensity score-weighted ENROLL-HD external control.","CMC validation: FDA agrees to use prior HEMGENIX knowledge, plus additional AMT-130 GMP batches and one PPQ batch; potency assay plan accepted pending qualification.","BLA submission targeting Q1 2026 with request for priority review; pre-BLA meeting in Q4 2025; Phase I/II topline data in Q3 2025.","Type B meetings held in Q1 and Q2 2025 on CMC and SAP; FDA aligned on statistical analysis plan including sensitivity analyses using TRACK-HD and PREDICT-HD datasets."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-055242","json":"https://secwatch.observer/filing/0001104659-25-055242.json","markdown":"https://secwatch.observer/filing/0001104659-25-055242.md","text":"https://secwatch.observer/filing/0001104659-25-055242.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925055242/0001104659-25-055242-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925055242/tm2516829d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T02:54:09.099823+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"}