{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-273467","form_type":"8-K","ticker":"RGNX","cik":"0001590877","company_name":"REGENXBIO Inc.","filed_at":"2024-12-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.899759+00:00","generated_at":"2026-05-29T05:39:06.715869+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"REGENXBIO initiates pivotal phase of RGX-202 Duchenne trial with positive functional data; signs $150M ATM facility","bullets":["First five patients in Phase I/II showed stable/improved function on NSAA and timed tests, exceeding external natural history controls.","FDA alignment achieved on accelerated approval pathway; BLA submission expected in 2026.","Biomarker data: RGX-202 microdystrophin expression highest reported; no serious adverse events.","New ATM sales agreement with Leerink Partners for up to $150M common stock, replacing prior BofA facility.","Pivotal trial enrolling ambulatory patients aged 1+, first patient dosed; includes younger boys aged 1-3."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-273467","json":"https://secwatch.observer/filing/0001193125-24-273467.json","markdown":"https://secwatch.observer/filing/0001193125-24-273467.md","text":"https://secwatch.observer/filing/0001193125-24-273467.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590877/000119312524273467/0001193125-24-273467-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590877/000119312524273467/d837203d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T05:39:06.715869+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"}