{"filing":{"accession_number":"0001193125-26-363786","cik":"0001590877","ticker":"RGNX","company_name":"REGENXBIO Inc.","form":"8-K","filing_date":"2026-08-24","report_date":"2026-08-24","primary_document":"rgnx-20260824.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/rgnx-20260824.htm"},"events":[{"id":29250,"run_id":26765,"accession_number":"0001193125-26-363786","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The FDA placed a clinical hold on RGX-121 following discovery of asymptomatic spine MRI findings in trial participants. The company does not expect to resubmit the BLA in the near term, representing a material regulatory setback to a late-stage gene therapy program.","company_name":"REGENXBIO Inc.","ticker":"RGNX","filing_date":"2026-08-24","form":"8-K","submitted_at":null,"items":[{"id":31454,"accession_number":"0001193125-26-363786","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA placed a clinical hold on RGX-121 following discovery of asymptomatic spine MRI findings in trial participants, and the company does not expect to resubmit the BLA in the near term. This is a material regulatory setback to a late-stage gene therapy program, but it is primarily an operational/clinical development event rather than a specific financial, legal, or governance matter. While it has significant business implications, it does not fit the defined categories of material_litigation, going_concern, or other terminal events—the company remains focused on other pipeline candidates with near-term catalysts.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-24T21:22:53.351804+00:00","company_name":"","ticker":null,"filing_date":""},{"id":31455,"accession_number":"0001193125-26-363786","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA placed a clinical hold on RGX-121 following discovery of asymptomatic spine MRI findings in five trial participants, and the company does not expect to resubmit the BLA in the near term. This is a material regulatory setback to a late-stage gene therapy program, but it is primarily an operational/clinical development event rather than a financial restatement, going-concern issue, or other specific terminal event. The company explicitly states it remains focused on other candidates with near-term catalysts, suggesting this is a significant but not existential setback.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-24T21:22:53.351804+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":31454,"accession_number":"0001193125-26-363786","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA placed a clinical hold on RGX-121 following discovery of asymptomatic spine MRI findings in trial participants, and the company does not expect to resubmit the BLA in the near term. This is a material regulatory setback to a late-stage gene therapy program, but it is primarily an operational/clinical development event rather than a specific financial, legal, or governance matter. While it has significant business implications, it does not fit the defined categories of material_litigation, going_concern, or other terminal events—the company remains focused on other pipeline candidates with near-term catalysts.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-24T21:22:53.351804+00:00","company_name":"REGENXBIO Inc.","ticker":"RGNX","filing_date":"2026-08-24"},{"id":31455,"accession_number":"0001193125-26-363786","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA placed a clinical hold on RGX-121 following discovery of asymptomatic spine MRI findings in five trial participants, and the company does not expect to resubmit the BLA in the near term. This is a material regulatory setback to a late-stage gene therapy program, but it is primarily an operational/clinical development event rather than a financial restatement, going-concern issue, or other specific terminal event. The company explicitly states it remains focused on other candidates with near-term catalysts, suggesting this is a significant but not existential setback.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-24T21:22:53.351804+00:00","company_name":"REGENXBIO Inc.","ticker":"RGNX","filing_date":"2026-08-24"}]}