{"schema_version":"secwatch.filing_event.v1","accession":"0001193805-23-000619","form_type":"8-K","ticker":"ARCT","cik":"0001768224","company_name":"Arcturus Therapeutics Holdings Inc.","filed_at":"2023-04-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.465939+00:00","generated_at":"2026-06-16T06:38:45.187961+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Meiji submits NDA in Japan for ARCT-154, Arcturus' self-amplifying mRNA COVID-19 vaccine","bullets":["Meiji Seika Pharma filed NDA for primary immunization (two doses) of ARCT-154 in Japan.","NDA based on Phase III trial in Vietnam (NCT05012943) with >16,000 subjects; met primary endpoint of COVID-19 prevention.","Meiji holds exclusive Japan distribution rights from CSL Seqirus; Arcturus developed the vaccine.","ARCT-154 uses next-gen mRNA technology for strong immune response and potential lower dosing.","Meiji collaborates with ARCALIS to build mRNA manufacturing in Minami-soma, Fukushima."],"urls":{"canonical":"https://secwatch.observer/filing/0001193805-23-000619","json":"https://secwatch.observer/filing/0001193805-23-000619.json","markdown":"https://secwatch.observer/filing/0001193805-23-000619.md","text":"https://secwatch.observer/filing/0001193805-23-000619.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1768224/000119380523000619/0001193805-23-000619-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1768224/000119380523000619/e618558_8k-arct.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T06:38:45.187961+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"}