{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-442648","form_type":"8-K","ticker":"INO","cik":"0001055726","company_name":"INOVIO PHARMACEUTICALS, INC.","filed_at":"2026-11-02T12:15:10+00:00","discovered_at":"2026-11-02T12:20:00.290933+00:00","generated_at":"2026-11-02T12:20:13.946830+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.92,"calibrated_materiality_score":0.92,"confidence":"high","headline":"Inovio wins FDA accelerated approval of VOCERYQ, first U.S.-approved DNA medicine, for RRP","bullets":["FDA granted accelerated approval for VOCERYQ (formerly INO-3107) to reduce frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).","Pivotal RRP-001: 7 of 26 efficacy patients (27%, 95% CI 12-48%) had complete response — no surgical excision 12 months after treatment; median 4.5 prior surgeries.","Inovio expects VOCERYQ to be orderable and shipping in about 60 days, with full field deployment in Q1 2027; Syneos Health engaged for commercial and medical field teams.","Confirmatory study required: draft protocol due to FDA by end of 2026, final protocol alignment expected mid-2027; continued approval contingent on verifying clinical benefit.","Inovio cites a prevalent U.S. RRP population of at least 25,000; VOCERYQ approved in combination with the CELLECTRA 5PSP delivery device."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-442648","json":"https://secwatch.observer/filing/0001193125-26-442648.json","markdown":"https://secwatch.observer/filing/0001193125-26-442648.md","text":"https://secwatch.observer/filing/0001193125-26-442648.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1055726/000119312526442648/0001193125-26-442648-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1055726/000119312526442648/d150457d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-02T12:20:13.946830+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"}