{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-363786","form_type":"8-K","ticker":"RGNX","cik":"0001590877","company_name":"REGENXBIO Inc.","filed_at":"2026-08-24T21:20:14+00:00","discovered_at":"2026-08-24T21:22:02.944939+00:00","generated_at":"2026-08-24T21:22:10.193304+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA clinical hold on REGENXBIO's RGX-121 for MPS II; BLA resubmission not expected near term","bullets":["FDA clinical hold on RGX-121 after asymptomatic spine MRI findings in 5 CAMPSIITE study participants.","REGENXBIO does not expect to resubmit RGX-121 BLA in near term; longer follow-up and data analysis needed.","All five participants clinically stable/improving; findings deemed nonserious, likely benign by investigators.","Company reaffirms Duchenne BLA submission this quarter and wet AMD pivotal data in Q4.","Hold follows earlier RGX-111 clinical hold; expanded MRI monitoring to include brain and spine."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-363786","json":"https://secwatch.observer/filing/0001193125-26-363786.json","markdown":"https://secwatch.observer/filing/0001193125-26-363786.md","text":"https://secwatch.observer/filing/0001193125-26-363786.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/0001193125-26-363786-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/rgnx-20260824.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-24T21:22:10.193304+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"}