{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-108802","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2025-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.844963+00:00","generated_at":"2026-05-16T22:24:43.148405+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"uniQure Q3 net loss $80.5M; FDA creates uncertainty for AMT-130 BLA","bullets":["Net loss of $80.5M ($1.38 loss per share) vs $44.4M loss in Q3 2024; revenue $3.7M (+$1.4M YoY).","Cash, cash equivalents and investments $694.2M as of Sept 30, 2025; raised ~$323.7M net from public offering.","AMT-130 Phase I/II topline: 75% slowing in cUHDRS (p=0.003), 60% in TFC (p=0.033) at 36 months vs external control.","Pre-BLA meeting with FDA: FDA no longer agrees Phase I/II data vs external control may support BLA; submission timing unclear.","R&D expenses $34.4M (+$3.8M YoY) driven by $6.6M in BLA preparation; SG&A $19.4M (+$7.8M YoY)."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-108802","json":"https://secwatch.observer/filing/0001104659-25-108802.json","markdown":"https://secwatch.observer/filing/0001104659-25-108802.md","text":"https://secwatch.observer/filing/0001104659-25-108802.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925108802/0001104659-25-108802-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465925108802/qure-20251110x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T22:24:43.148405+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"}