{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-008845","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2024-06-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.115790+00:00","generated_at":"2026-06-01T06:48:31.745759+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 receives FDA RMAT designation for gene therapy AMT-130 in Huntington's disease","bullets":["FDA granted RMAT designation for AMT-130 based on 24-month Phase I/II data vs. natural history cohort.","First RMAT designation ever for a Huntington's disease therapy, enabling fast track and breakthrough therapy benefits.","Designation allows increased collaboration with FDA on accelerated approval pathways and expedited development.","uniQure expects to provide updated interim data from Phase I/II studies in mid-2024, including up to 3-year follow-up on 29 patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-008845","json":"https://secwatch.observer/filing/0001558370-24-008845.json","markdown":"https://secwatch.observer/filing/0001558370-24-008845.md","text":"https://secwatch.observer/filing/0001558370-24-008845.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024008845/0001558370-24-008845-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024008845/qure-20240603x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T06:48:31.745759+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"}