{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-052112","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2026-04-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.531830+00:00","generated_at":"2026-05-15T00:56:32.271424+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"uniQure plans UK MAA submission for AMT-130 in Q3 2026 after successful MHRA meeting","bullets":["Successful MHRA pre-submission meeting for AMT-130 gene therapy in Huntington's disease.","Expected MAA submission in Q3 2026 based on Phase I/II three-year data showing 75% slowing of disease progression at high dose.","FDA Type B meeting granted in Q2 2026 to discuss potential Phase III design and four-year analysis plan.","Actively pursuing additional ex-US regulatory pathways for AMT-130; updates expected H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-052112","json":"https://secwatch.observer/filing/0001104659-26-052112.json","markdown":"https://secwatch.observer/filing/0001104659-26-052112.md","text":"https://secwatch.observer/filing/0001104659-26-052112.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926052112/0001104659-26-052112-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926052112/qure-20260430x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T00:56:32.271424+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"}