{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-050211","form_type":"8-K","ticker":"OSTX","cik":"0001795091","company_name":"OS Therapies Inc","filed_at":"2026-04-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.921569+00:00","generated_at":"2026-05-15T01:03:37.644565+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"EMA rolling review for OST-HER2; ATGA aligns on 3-year OS endpoint; peak EU sales >$300M","bullets":["EMA initiated rolling review of OST-HER2 CMA for preventing recurrence in resected pulmonary metastatic osteosarcoma.","EMA and Australia TGA agreed 3-year overall survival as approvable endpoint; seroconversion data supports CMA.","UK MHRA granted Advanced Therapy Medicinal Product (ATMP) designation to OST-HER2.","Company forecasts peak European osteosarcoma sales exceeding $300M, with over $50M expected in 2027.","Confirmatory Phase 3 trial initiation planned for Q3 2026 in Australia; FDA and MHRA meetings in Q2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-050211","json":"https://secwatch.observer/filing/0001213900-26-050211.json","markdown":"https://secwatch.observer/filing/0001213900-26-050211.md","text":"https://secwatch.observer/filing/0001213900-26-050211.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1795091/000121390026050211/0001213900-26-050211-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1795091/000121390026050211/ea0288588-8k_ostherapies.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T01:03:37.644565+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"}