{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-307516","form_type":"8-K","ticker":"ATOS","cik":"0001488039","company_name":"ATOSSA THERAPEUTICS, INC.","filed_at":"2025-12-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.512867+00:00","generated_at":"2026-05-16T14:37:03.285365+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Atossa completes FDA Type C meeting; gains clarity on accelerated (Z)-endoxifen development","bullets":["FDA provided feedback on regulatory pathways for (Z)-endoxifen across metastatic, neoadjuvant, and risk-reduction settings.","Company submitted IND for metastatic breast cancer program and awaits FDA feedback.","Phase 2 EVANGELINE trial continuing in neoadjuvant ER+/HER2- breast cancer.","Nearly 800 participants in completed trials; no MTD identified up to 360 mg/day.","Additional IND submissions planned in 2026 for combination strategies beyond monotherapy and breast cancer."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-307516","json":"https://secwatch.observer/filing/0001193125-25-307516.json","markdown":"https://secwatch.observer/filing/0001193125-25-307516.md","text":"https://secwatch.observer/filing/0001193125-25-307516.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1488039/000119312525307516/0001193125-25-307516-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1488039/000119312525307516/atos-20251204.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:37:03.285365+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"}