{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-026139","form_type":"8-K","ticker":"RGNX","cik":"0001590877","company_name":"REGENXBIO Inc.","filed_at":"2026-01-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.566197+00:00","generated_at":"2026-05-16T06:59:46.316829+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA places clinical hold on REGENXBIO's RGX-111 and RGX-121 gene therapies after neoplasm case","bullets":["Single neoplasm (intraventricular CNS tumor) found in 5-year-old asymptomatic patient 4 years post-RGX-111 dose; AAV vector integration detected near PLAG1 proto-oncogene.","RGX-121 placed on hold due to product, population, and risk similarities with RGX-111.","No neoplasms reported in 9 other RGX-111 or 32 RGX-121 patients.","CEO surprised by RGX-121 hold while investigation continues; confident in benefit-risk based on positive safety and efficacy data.","Company has not yet received full clinical hold letter and awaits FDA details."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-026139","json":"https://secwatch.observer/filing/0001193125-26-026139.json","markdown":"https://secwatch.observer/filing/0001193125-26-026139.md","text":"https://secwatch.observer/filing/0001193125-26-026139.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590877/000119312526026139/0001193125-26-026139-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590877/000119312526026139/rgnx-20260123.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T06:59:46.316829+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"}