{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-111654","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2026-09-29T13:05:32+00:00","discovered_at":"2026-09-29T13:06:00.228317+00:00","generated_at":"2026-10-12T13:44:09.426476+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"uniQure reports AMT-130 Phase I/II data: 80% slowing of Huntington's progression at 36 months in high-dose patients","bullets":["At 36 months, 15 high-dose patients showed 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (p=0.011) vs the updated ENROLL-HD external control.","At 48 months (n=12 high dose), cUHDRS slowing was 44% (p=0.144, not significant) and TFC 61% (p=0.008); a post-hoc prior-control analysis showed 53.5% and 68.3%.","FDA said 36-month data from 12 high-dose patients could support the accelerated-approval BLA, which was submitted before today's topline results were available.","Five high-dose patients (17%) had treatment-related serious adverse events from CNS inflammation, all resolved; one low-dose patient suicide ~5 years post-treatment was assessed as unrelated.","uniQure hosts an investor call today at 8:30 a.m. ET; AMT-130 holds FDA Breakthrough Therapy, RMAT and Fast Track designations."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-111654","json":"https://secwatch.observer/filing/0001104659-26-111654.json","markdown":"https://secwatch.observer/filing/0001104659-26-111654.md","text":"https://secwatch.observer/filing/0001104659-26-111654.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926111654/0001104659-26-111654-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926111654/tm2626514d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:44:09.426476+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"}