{"schema_version":"secwatch.filing_event.v1","accession":"0001193805-25-001499","form_type":"8-K","ticker":"ARCT","cik":"0001768224","company_name":"Arcturus Therapeutics Holdings Inc.","filed_at":"2025-10-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.367967+00:00","generated_at":"2026-05-17T02:47:49.505343+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Arcturus reports ARCT-032 CF interim data showing mucus reduction; KOSTAIVE BLA submission delayed by FDA","bullets":["ARCT-032 Phase 2 interim: generally safe/tolerated; 4 of 6 Class I CF patients showed mucus plug/volume reduction after 28 days (10 mg).","FDA requested delay of KOSTAIVE BLA submission (Sep 5), then required additional clinical endpoint efficacy study per updated COVID-19 framework.","CSL Seqirus submitted KOSTAIVE MAA to UK MHRA in June 2025; approval expected Q1 2026, but not assured.","Company filed lawsuit Sep 23, 2025 against AbbVie and Capstan Therapeutics for trade secret misappropriation and breach of contract.","12-week safety/efficacy study of ARCT-032 in up to 20 CF participants planned to start first half of 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193805-25-001499","json":"https://secwatch.observer/filing/0001193805-25-001499.json","markdown":"https://secwatch.observer/filing/0001193805-25-001499.md","text":"https://secwatch.observer/filing/0001193805-25-001499.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1768224/000119380525001499/0001193805-25-001499-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1768224/000119380525001499/e664913_8k-arct.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T02:47:49.505343+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"}