{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-396094","form_type":"8-K","ticker":"CUE","cik":"0001645460","company_name":"Cue Biopharma, Inc.","filed_at":"2026-09-21T12:00:17+00:00","discovered_at":"2026-09-21T12:05:32.789935+00:00","generated_at":"2026-09-21T12:05:57.923659+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":"Cue Biopharma: CUE-221 Phase 2 in CSU meets primary and key secondary endpoints","bullets":["Phase 2 trial (N=145) met primary endpoint HSS7=0 at week 12 at all doses: 54% (4mg/kg) vs 11% placebo, p<0.005.","Key secondary endpoint UAS7=0 met at 4mg/kg: 46% vs 11% placebo, p<0.05; dose-responsive.","Safety favorable: no treatment-related SAEs or anaphylaxis; only one >grade1 injection site reaction, none led to discontinuation.","Plans to initiate Phase 2b/3 in CSU and Phase 2 in food allergy; IND for food allergy submitted to FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-396094","json":"https://secwatch.observer/filing/0001193125-26-396094.json","markdown":"https://secwatch.observer/filing/0001193125-26-396094.md","text":"https://secwatch.observer/filing/0001193125-26-396094.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645460/000119312526396094/0001193125-26-396094-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645460/000119312526396094/d21238d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-21T12:05:57.923659+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"}