{"schema_version":"secwatch.filing_event.v1","accession":"0001193805-23-000929","form_type":"8-K","ticker":"ARCT","cik":"0001768224","company_name":"Arcturus Therapeutics Holdings Inc.","filed_at":"2023-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.466765+00:00","generated_at":"2026-06-13T14:13:00.642141+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 submits additional application in Japan for booster dose of Arcturus' COVID-19 vaccine ARCT-154","bullets":["Meiji Seika Pharma submitted a booster dose application for ARCT-154 in Japan based on Phase III data meeting primary endpoint.","This follows the April 28 NDA for primary immunization; ARCT-154 is a self-amplifying mRNA vaccine developed by Arcturus.","The Phase III trial (jRCT2071220080) compared ARCT-154 to COMIRNATY booster; no clinically significant safety concerns.","If approved, ARCT-154 would be a new COVID-19 vaccination option in Japan; distribution via CSL Seqirus agreement."],"urls":{"canonical":"https://secwatch.observer/filing/0001193805-23-000929","json":"https://secwatch.observer/filing/0001193805-23-000929.json","markdown":"https://secwatch.observer/filing/0001193805-23-000929.md","text":"https://secwatch.observer/filing/0001193805-23-000929.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1768224/000119380523000929/0001193805-23-000929-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1768224/000119380523000929/e618740_8k-arct.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T14:13:00.642141+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"}