{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-109829","form_type":"8-K","ticker":"RGNX","cik":"0001590877","company_name":"REGENXBIO Inc.","filed_at":"2025-08-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.446712+00:00","generated_at":"2026-05-17T11:55:53.797325+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA extends PDUFA date for RGX-121 BLA to February 8, 2026","bullets":["PDUFA goal date extended from Nov 9, 2025 to Feb 8, 2026 for review of additional 12-month data from pivotal study (n=13).","No safety concerns raised; pre-license inspection completed with no observations.","Company to present updated pivotal data at ICIEM meeting in September 2025; commercial launch plans remain on track.","RGX-121 would be first potential one-time therapy for MPS II (Hunter syndrome); holds FDA Orphan, Rare Pediatric, Fast Track, RMAT designations."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-109829","json":"https://secwatch.observer/filing/0000950170-25-109829.json","markdown":"https://secwatch.observer/filing/0000950170-25-109829.md","text":"https://secwatch.observer/filing/0000950170-25-109829.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590877/000095017025109829/0000950170-25-109829-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590877/000095017025109829/rgnx-20250818.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:55:53.797325+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"}