{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-000402","form_type":"8-K","ticker":"ZBIO","cik":"0001953926","company_name":"Zenas BioPharma, Inc.","filed_at":"2026-01-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.867274+00:00","generated_at":"2026-05-16T11:44:01.528063+00:00","sec_items":["2.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Zenas BioPharma reports positive Phase 3 INDIGO trial of obexelimab in IgG4-RD; plans BLA in Q2 2026","bullets":["Obexelimab met primary endpoint: 56% reduction in IgG4-RD flare risk vs placebo (HR 0.443, p=0.0005).","All four key secondary endpoints met with high statistical significance (p≤0.0049).","Safety profile favorable: SAEs 10% obexelimab vs 19% placebo; fewer infections.","Preliminary cash $360.5M as of Dec 31, 2025; expected to fund operations through end of 2026.","BLA submission to FDA planned Q2 2026; MAA to EMA H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-000402","json":"https://secwatch.observer/filing/0001104659-26-000402.json","markdown":"https://secwatch.observer/filing/0001104659-26-000402.md","text":"https://secwatch.observer/filing/0001104659-26-000402.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1953926/000110465926000402/0001104659-26-000402-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1953926/000110465926000402/tm261774d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:44:01.528063+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"}