{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-021890","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2026-03-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.562368+00:00","generated_at":"2026-05-15T22:39:25.726769+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"FDA rejects AMT-130 Phase I/II data as sufficient for approval; recommends randomized sham-controlled study","bullets":["Net loss of $199.0M for 2025 vs $239.6M in 2024; revenue $16.1M down 41% YoY.","Cash and investments $622.5M, expected to fund operations into H2 2029.","FDA stated Phase I/II data vs external control insufficient for marketing application; strongly recommends prospective, randomized, double-blind, sham surgery-controlled study.","Company plans to request Type B meeting in Q2 2026 to discuss Phase III study design.","AMT-260 MTLE Phase I/IIa enrollment completed in first cohort; data expected H1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-021890","json":"https://secwatch.observer/filing/0001104659-26-021890.json","markdown":"https://secwatch.observer/filing/0001104659-26-021890.md","text":"https://secwatch.observer/filing/0001104659-26-021890.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926021890/0001104659-26-021890-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926021890/qure-20260302x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T22:39:25.726769+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"}