{"filing":{"accession_number":"0001104659-26-104463","cik":"0001590560","ticker":"QURE","company_name":"uniQure N.V.","form":"8-K","filing_date":"2026-09-02","report_date":"2026-09-02","primary_document":"qure-20260902x8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1590560/000110465926104463/qure-20260902x8k.htm"},"events":[{"id":31145,"run_id":28570,"accession_number":"0001104659-26-104463","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"uniQure announced the submission of a Biologics License Application (BLA) to the FDA for accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington's disease treatment, along with a Marketing Authorisation Application (MAA) to the UK's MHRA. This represents a material regulatory milestone in the clinical development and commercialization pathway for a lead gene therapy candidate, supported by three-year Phase I/II data. While this is a significant operational and strategic event for the company's pipeline, it does not fit neatly into the specific event categories (e.g., it is not an earnings release, M\u0026A activity, or a specific financial obligation), making it best classified as an operational milestone that would materially affect investor assessment of the company's progress toward commercialization.","company_name":"uniQure N.V.","ticker":"QURE","filing_date":"2026-09-02","form":"8-K","submitted_at":null,"items":[{"id":33949,"accession_number":"0001104659-26-104463","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"uniQure announced the submission of a Biologics License Application (BLA) to the FDA for accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington's disease treatment, along with a Marketing Authorisation Application (MAA) to the UK's MHRA. This represents a material regulatory milestone in the clinical development and commercialization pathway for a lead gene therapy candidate, supported by three-year Phase I/II data. While this is a significant operational and strategic event for the company's pipeline, it does not fit neatly into the specific event categories (e.g., it is not an earnings release, M\u0026A activity, or a specific financial obligation), making it best classified as an operational milestone that would materially affect investor assessment of the company's progress toward commercialization.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-02T11:06:53.476097+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":33949,"accession_number":"0001104659-26-104463","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"uniQure announced the submission of a Biologics License Application (BLA) to the FDA for accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington's disease treatment, along with a Marketing Authorisation Application (MAA) to the UK's MHRA. This represents a material regulatory milestone in the clinical development and commercialization pathway for a lead gene therapy candidate, supported by three-year Phase I/II data. While this is a significant operational and strategic event for the company's pipeline, it does not fit neatly into the specific event categories (e.g., it is not an earnings release, M\u0026A activity, or a specific financial obligation), making it best classified as an operational milestone that would materially affect investor assessment of the company's progress toward commercialization.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-02T11:06:53.476097+00:00","company_name":"uniQure N.V.","ticker":"QURE","filing_date":"2026-09-02"}]}