{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-332322","form_type":"8-K","ticker":"INO","cik":"0001055726","company_name":"INOVIO PHARMACEUTICALS, INC.","filed_at":"2025-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.677037+00:00","generated_at":"2026-05-16T12:03:58.301932+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA accepts INOVIO's BLA for INO-3107; standard review, PDUFA Oct 2026, but flags accelerated approval issue","bullets":["BLA accepted for review; FDA classified as standard; no advisory committee planned.","PDUFA goal date October 30, 2026.","FDA preliminary conclusion: inadequate info to justify accelerated approval eligibility.","Company to request meeting with FDA to discuss accelerated approval; not pursuing traditional pathway.","INO-3107 is investigational immunotherapy for recurrent respiratory papillomatosis (RRP) in adults."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-332322","json":"https://secwatch.observer/filing/0001193125-25-332322.json","markdown":"https://secwatch.observer/filing/0001193125-25-332322.md","text":"https://secwatch.observer/filing/0001193125-25-332322.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1055726/000119312525332322/0001193125-25-332322-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1055726/000119312525332322/d78035d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:03:58.301932+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"}