{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-24-016106","form_type":"8-K","ticker":"QURE","cik":"0001590560","company_name":"uniQure N.V.","filed_at":"2024-12-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.896508+00:00","generated_at":"2026-05-29T05:10:45.614585+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"uniQure reaches FDA alignment on Accelerated Approval pathway for AMT-130 in Huntington's disease","bullets":["FDA agrees data from ongoing Phase I/II studies vs natural history external control may serve as primary basis for BLA under Accelerated Approval.","FDA agrees cUHDRS may serve as intermediate clinical endpoint; reductions in CSF NfL provide supportive evidence of benefit.","Company initiated BLA readiness activities; plans to discuss statistical analysis plan and CMC requirements with FDA in H1 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-24-016106","json":"https://secwatch.observer/filing/0001558370-24-016106.json","markdown":"https://secwatch.observer/filing/0001558370-24-016106.md","text":"https://secwatch.observer/filing/0001558370-24-016106.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024016106/0001558370-24-016106-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590560/000155837024016106/qure-20241210x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T05:10:45.614585+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"}