{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-385901","form_type":"8-K","ticker":"PYXS","cik":"0001782223","company_name":"Pyxis Oncology, Inc.","filed_at":"2026-09-09T11:34:45+00:00","discovered_at":"2026-09-09T11:40:00.659760+00:00","generated_at":"2026-09-09T11:40:07.217042+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Pyxis Oncology reports 36% cORR, 94% DCR for MICVO in 2L+ HNSCC; Phase 3 planned mid-2027","bullets":["MICVO Phase 1 in 2L+ R/M HNSCC: cORR 36% (12/33), DCR 94% (31/33), mPFS 6.2 months, 12-month OS 79%.","Median OS not reached; 83% of responders had >50% tumor reduction; 75% responded by first scan at 6 weeks.","No new safety signals; dose capping reduced frequency/severity of AEs in high body weight patients; no treatment-related deaths.","Phase 3 Headliner trial planned to initiate mid-2027; FDA/EMA aligned on design; End of Phase 2 meeting Q1 2027.","Combination with KEYTRUDA data expected Q4 2026; updated OS data from monotherapy expected H1 2027."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-385901","json":"https://secwatch.observer/filing/0001193125-26-385901.json","markdown":"https://secwatch.observer/filing/0001193125-26-385901.md","text":"https://secwatch.observer/filing/0001193125-26-385901.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1782223/000119312526385901/0001193125-26-385901-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1782223/000119312526385901/pyxs-20260909.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-09T11:40:07.217042+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"}