{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-119079","form_type":"8-K","ticker":"ZURA","cik":"0001855644","company_name":"Zura Bio Ltd","filed_at":"2024-11-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:10.091327+00:00","generated_at":"2026-05-30T00:37:22.894881+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Zura Bio submits Phase 2 protocol for tibulizumab in systemic sclerosis to FDA","bullets":["Protocol submitted to open IND for Phase 2 study of tibulizumab (IL-17A/BAFF dual antagonist) in adults with systemic sclerosis.","Study is double-blind, randomized (1:1), placebo-controlled, targeting ~80 participants with early diffuse cutaneous SSc.","Trial expected to initiate in Q4 2024; Orphan Drug Designation request also submitted to FDA same quarter.","Tibulizumab is investigational; no regulatory approval yet for systemic sclerosis or any indication.","CEO cites significant unmet need as current SSc treatments only target interstitial lung disease component."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-119079","json":"https://secwatch.observer/filing/0001104659-24-119079.json","markdown":"https://secwatch.observer/filing/0001104659-24-119079.md","text":"https://secwatch.observer/filing/0001104659-24-119079.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1855644/000110465924119079/0001104659-24-119079-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1855644/000110465924119079/tm2428489d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T00:37:22.894881+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"}