{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-26-006162","form_type":"8-K","ticker":"CMPX","cik":"0001738021","company_name":"Compass Therapeutics, Inc.","filed_at":"2026-09-22T12:30:16+00:00","discovered_at":"2026-09-22T12:35:01.437625+00:00","generated_at":"2026-09-22T12:35:24.183603+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA tells Compass to run survival trial before BLA for tovecimig; company disagrees","bullets":["FDA recommended a survival-benefit trial before BLA submission for tovecimig in biliary tract cancer (BTC).","Compass disagrees, citing COMPANION-002: ORR 18.0% vs 5.3% (p=0.0228); median PFS 4.7 vs 2.6 months, HR 0.44 (p<0.0001).","Overall survival missed statistical significance due to high crossover and prolonged survival in crossover patients.","Company plans further FDA engagement, intends to proceed with BLA; full data to be presented at a medical conference this year.","CEO Thomas Schuetz acknowledged the feedback and said priority is working with the FDA on the best path forward."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-26-006162","json":"https://secwatch.observer/filing/0001171843-26-006162.json","markdown":"https://secwatch.observer/filing/0001171843-26-006162.md","text":"https://secwatch.observer/filing/0001171843-26-006162.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1738021/000117184326006162/0001171843-26-006162-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1738021/000117184326006162/f8k_092226.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-22T12:35:24.183603+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"}