{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-253450","form_type":"8-K","ticker":"INO","cik":"0001055726","company_name":"INOVIO PHARMACEUTICALS, INC.","filed_at":"2023-10-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.058303+00:00","generated_at":"2026-06-10T01:59:48.377628+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"INOVIO gets FDA nod to use Phase 1/2 data for INO-3107 BLA under accelerated approval; Phase 3 waived","bullets":["FDA confirmed that completed Phase 1/2 trial data for INO-3107 in RRP can support BLA under accelerated approval; previously planned Phase 3 trial no longer required.","Confirmatory trial must be initiated before BLA submission; design not yet finalized.","If approved, INO-3107 would be first DNA medicine in the US and INOVIO's first commercial product.","Phase 1/2 results: 81.3% (26/32) of patients had fewer surgical interventions; median reduction of 3 surgeries; strong T-cell immune response with durable memory.","Cash runway guidance may change; company plans to provide updated cash guidance on Q3 2023 earnings call in November."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-253450","json":"https://secwatch.observer/filing/0001193125-23-253450.json","markdown":"https://secwatch.observer/filing/0001193125-23-253450.md","text":"https://secwatch.observer/filing/0001193125-23-253450.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1055726/000119312523253450/0001193125-23-253450-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1055726/000119312523253450/d567242d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T01:59:48.377628+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"}