{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-113371","form_type":"8-K","ticker":"ATOS","cik":"0001488039","company_name":"ATOSSA THERAPEUTICS, INC.","filed_at":"2025-09-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.098744+00:00","generated_at":"2026-05-17T07:32:48.665566+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Atossa requests FDA Type C meeting to accelerate low-dose (Z)-endoxifen for breast cancer risk reduction","bullets":["Company requested a Type C FDA meeting; expects update by year-end 2025.","Favorable outcome could shorten approval timeline by years and avoid tens of millions in trial costs.","Cash position of $57.9M with no debt as of June 30, 2025; potential multi-billion-dollar market highlighted.","Annual U.S. tamoxifen prescriptions estimated at 1.6-2.1 million; 4.3M women live with breast cancer history.","(Z)-endoxifen avoids CYP2D6 metabolism issues affecting ~20% of tamoxifen patients."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-113371","json":"https://secwatch.observer/filing/0000950170-25-113371.json","markdown":"https://secwatch.observer/filing/0000950170-25-113371.md","text":"https://secwatch.observer/filing/0000950170-25-113371.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1488039/000095017025113371/0000950170-25-113371-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1488039/000095017025113371/atos-20250908.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T07:32:48.665566+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"}