{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-22-032097","form_type":"8-K","ticker":"ARQT","cik":"0001787306","company_name":"Arcutis Biotherapeutics, Inc.","filed_at":"2022-12-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:52.118624+00:00","generated_at":"2026-06-21T03:29:52.928375+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Arcutis reports positive Phase 3 results for roflumilast cream 0.15% in atopic dermatitis","bullets":["INTEGUMENT-1: 32.0% of roflumilast patients achieved IGA success vs 15.2% vehicle (p<0.0001); INTEGUMENT-2: 28.9% vs 12.0% (p<0.0001).","Key secondary endpoints met: EASI-75 (43.2% vs 22% in INTEGUMENT-1) and WI-NRS itch reduction (33.6% vs 20.7% in INTEGUMENT-1) at week 4.","Roflumilast cream was well-tolerated with low TEAEs; discontinuation rates low (<2%) in both trials.","Total 1,337 subjects enrolled across both trials (654 in INTEGUMENT-1, 683 in INTEGUMENT-2); completed study rates ~93% and 90%.","Company posted updated corporate presentation with trial details; results support potential NDA submission."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-22-032097","json":"https://secwatch.observer/filing/0001628280-22-032097.json","markdown":"https://secwatch.observer/filing/0001628280-22-032097.md","text":"https://secwatch.observer/filing/0001628280-22-032097.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1787306/000162828022032097/0001628280-22-032097-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1787306/000162828022032097/arqt-20221212.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T03:29:52.928375+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"}