{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-032205","form_type":"8-K","ticker":"RGNX","cik":"0001590877","company_name":"REGENXBIO Inc.","filed_at":"2022-02-09T23:59:59+00:00","discovered_at":"2026-05-14T18:04:07.242410+00:00","generated_at":"2026-06-27T09:36:46.385116+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"REGENXBIO reports positive interim Phase I/II data for RGX-121 (MPS II) and RGX-111 (MPS I)","bullets":["Both RGX-121 (13 pts) and RGX-111 (5 pts + single-patient IND) well-tolerated with no drug-related SAEs.","RGX-121: Dose-dependent CSF biomarker reductions; Cohort 3 D2S6 near normal levels at last follow-up.","RGX-111: CSF heparan sulfate decreased in all 4 patients; IDUA enzyme detected in 3 of 4 post-dose.","Neurodevelopmental improvement: RGX-121 patients (Cohorts 1-2) show skill acquisition up to 2 years; RGX-111 shows gains in younger and one older patient.","Next steps: RGX-121 Cohort 3 expansion with cGMP material planned 1H2022; RGX-111 Cohort 2 expanded to enroll up to 6 more patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-032205","json":"https://secwatch.observer/filing/0001193125-22-032205.json","markdown":"https://secwatch.observer/filing/0001193125-22-032205.md","text":"https://secwatch.observer/filing/0001193125-22-032205.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590877/000119312522032205/0001193125-22-032205-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590877/000119312522032205/d276078d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T09:36:46.385116+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"}