{"schema_version":"secwatch.filing_event.v1","accession":"0001835268-25-000019","form_type":"8-K","ticker":"CNTB","cik":"0001835268","company_name":"Connect Biopharma Holdings Ltd","filed_at":"2025-04-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.032329+00:00","generated_at":"2026-05-24T01:05:44.996486+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Connect Biopharma gains FDA alignment for Phase 2 trials of rademikibart in acute asthma/COPD","bullets":["FDA Type C meeting positive; agency aligned on parallel Phase 2 trials for rademikibart in acute exacerbations of asthma or COPD.","Two placebo-controlled trials each enrolling ~160 patients with eosinophils ≥300 cells/µL; single 600 mg SC dose over 28 days.","Initiation planned in Q2 2025; data expected in first half of 2026; cash runway into 2027.","CEO cites prior Phase 2 maintenance data showing rapid lung function improvement within 24 hours of 600 mg dose.","Unmet need highlighted: ~45% of patients on standard of care experience treatment failure within 28 days post-exacerbation."],"urls":{"canonical":"https://secwatch.observer/filing/0001835268-25-000019","json":"https://secwatch.observer/filing/0001835268-25-000019.json","markdown":"https://secwatch.observer/filing/0001835268-25-000019.md","text":"https://secwatch.observer/filing/0001835268-25-000019.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835268/000183526825000019/0001835268-25-000019-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835268/000183526825000019/cntb-20250401.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T01:05:44.996486+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"}