{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-003506","form_type":"8-K","ticker":"ATOS","cik":"0001488039","company_name":"ATOSSA THERAPEUTICS, INC.","filed_at":"2026-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.186625+00:00","generated_at":"2026-05-16T11:31:47.527466+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Atossa Therapeutics receives FDA 'Study May Proceed' letter for (Z)-Endoxifen metastatic breast cancer trial","bullets":["FDA issued 'Study May Proceed' letter for Atossa's IND for (Z)-Endoxifen in metastatic ER+/HER2- breast cancer.","Trial will evaluate (Z)-Endoxifen in tumors resistant to other endocrine therapies; targets PKCβ1 pathway.","CEO Dr. Steven Quay calls this an important regulatory milestone to expand (Z)-Endoxifen's potential use.","(Z)-Endoxifen is a potent SERM/D with distinct pharmacology from tamoxifen; not yet approved for any indication.","Program backed by growing global IP portfolio including issued U.S. patents and pending applications."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-003506","json":"https://secwatch.observer/filing/0001193125-26-003506.json","markdown":"https://secwatch.observer/filing/0001193125-26-003506.md","text":"https://secwatch.observer/filing/0001193125-26-003506.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1488039/000119312526003506/0001193125-26-003506-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1488039/000119312526003506/atos-20260106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:31:47.527466+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"}