{"schema_version":"secwatch.filing_event.v1","accession":"0001193805-25-001247","form_type":"8-K","ticker":"ARCT","cik":"0001768224","company_name":"Arcturus Therapeutics Holdings Inc.","filed_at":"2025-08-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.925393+00:00","generated_at":"2026-05-17T09:15:14.566028+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Meiji Seika Pharma receives Japan approval for two-dose vial of KOSTAIVE® COVID-19 vaccine","bullets":["Approval granted August 28, 2025 for new two-dose vial presentation of KOSTAIVE® (ARCT-2301) in Japan.","Vaccine targets SARS-CoV-2 Omicron sub lineage JN.1 variant XEC; induces neutralizing antibodies against multiple variants.","Meiji Seika Pharma plans to begin supply of the new presentation starting late September 2025.","Non-clinical data shows neutralizing antibodies against JN.1, XEC, LP.8.1, XFG, and NB.1.8.1 variants.","Distribution in Japan is under a prior agreement between Meiji and CSL Seqirus, partner of Arcturus."],"urls":{"canonical":"https://secwatch.observer/filing/0001193805-25-001247","json":"https://secwatch.observer/filing/0001193805-25-001247.json","markdown":"https://secwatch.observer/filing/0001193805-25-001247.md","text":"https://secwatch.observer/filing/0001193805-25-001247.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1768224/000119380525001247/0001193805-25-001247-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1768224/000119380525001247/e664805_8k-arct.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T09:15:14.566028+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"}