{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-012941","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2024-09-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.673889+00:00","generated_at":"2026-05-31T02:26:31.544480+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"uniQure receives FDA Orphan Drug Designation for AMT-191 gene therapy for Fabry disease","bullets":["FDA granted Orphan Drug Designation to AMT-191 for Fabry disease on Sep 23, 2024.","AMT-191 is a one-time IV AAV5-based gene therapy delivering a GLA transgene.","First patient dosed in Aug 2024 in a U.S. multi-center open-label Phase I/IIa trial.","Designation provides tax credits, fee waivers, and 7-year US market exclusivity if approved.","Initial Phase I/IIa clinical data expected in 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-012941","json":"https://secwatch.observer/filing/0001558370-24-012941.json","markdown":"https://secwatch.observer/filing/0001558370-24-012941.md","text":"https://secwatch.observer/filing/0001558370-24-012941.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024012941/0001558370-24-012941-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024012941/qure-20240923x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T02:26:31.544480+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"}