{"schema_version":"secwatch.filing_event.v1","accession":"0001835268-26-000038","form_type":"8-K","ticker":"CNTB","cik":"0001835268","company_name":"Connect Biopharma Holdings Ltd","filed_at":"2026-09-30T11:05:05+00:00","discovered_at":"2026-09-30T11:10:00.129479+00:00","generated_at":"2026-10-12T13:56:58.128770+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":"Connect Biopharma's rademikibart cuts COPD treatment failure 81% in Phase 2; plans FDA Phase 3 talks","bullets":["Phase 2 Seabreeze STAT (CBP-201-207) enrolled 159 COPD patients with eosinophils >=300 cells/uL; randomized 1:1 to single subcutaneous rademikibart or placebo plus standard of care.","Treatment failure rate fell 81% through Week 4 vs placebo (p=0.0122); new moderate-to-severe COPD exacerbations fell 85% (p=0.030).","ED visits and hospital admissions for new exacerbations reduced 100% (p=0.0137); rescue inhaler use cut from Week 2-7 with symptom improvement at Week 2 (p=0.0197).","FEV1 improved 70 mL at Week 4 vs placebo but missed significance (p=0.1607); rademikibart well tolerated with lower adverse and serious adverse event rates than placebo.","CEO Barry Quart cited 2025 claims data showing ~$6B in 30-day COPD ED return-visit costs; Connect plans to engage FDA on a Phase 3 registrational program."],"urls":{"canonical":"https://secwatch.observer/filing/0001835268-26-000038","json":"https://secwatch.observer/filing/0001835268-26-000038.json","markdown":"https://secwatch.observer/filing/0001835268-26-000038.md","text":"https://secwatch.observer/filing/0001835268-26-000038.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835268/000183526826000038/0001835268-26-000038-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835268/000183526826000038/cntb-20260930.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:56:58.128770+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"}