{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-092740","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2025-09-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.444906+00:00","generated_at":"2026-05-17T05:46:25.794799+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"uniQure AMT-130 Phase I/II meets primary endpoint: 75% HD progression slowing at 36 months","bullets":["High-dose AMT-130 showed 75% slowing on cUHDRS (p=0.003) vs external control; key secondary TFC endpoint also met (60% slowing, p=0.033).","Mean CSF NfL reduced 8.2% from baseline at 36 months, supporting potential disease modification.","No new drug-related serious adverse events since Dec 2022; manageable safety profile.","Company plans pre-BLA meeting with FDA later 2025, BLA submission targeted for Q1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-092740","json":"https://secwatch.observer/filing/0001104659-25-092740.json","markdown":"https://secwatch.observer/filing/0001104659-25-092740.md","text":"https://secwatch.observer/filing/0001104659-25-092740.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925092740/0001104659-25-092740-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925092740/qure-20250924x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:46:25.794799+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"}