{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-013276","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2024-10-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.895875+00:00","generated_at":"2026-05-30T14:34:13.099090+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"confidence":"high","headline":"uniQure doses first patient in Phase I/II trial of AMT-162 gene therapy for SOD1-ALS","bullets":["First patient dosed in EPISOD1 Phase I/II open-label trial of AMT-162 for SOD1-ALS, a rare inherited progressive motor neuron disease.","Trial has three dose-escalating cohorts; up to four patients per cohort receiving intrathecal AMT-162 with immunosuppression.","AMT-162 is an AAVrh10-based gene therapy expressing miRNA to knock down mutated SOD1 protein; granted Orphan Drug and Fast Track FDA designations.","Four active U.S. sites; plans to activate seven additional sites by Q1 2025.","Trial will assess safety, tolerability, and exploratory efficacy via neurofilament light chain and SOD1 protein biomarkers."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-013276","json":"https://secwatch.observer/filing/0001558370-24-013276.json","markdown":"https://secwatch.observer/filing/0001558370-24-013276.md","text":"https://secwatch.observer/filing/0001558370-24-013276.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024013276/0001558370-24-013276-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024013276/qure-20241015x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T14:34:13.099090+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"}