{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-112969","form_type":"8-K","ticker":"KZR","cik":"0001645666","company_name":"Kezar Life Sciences, Inc.","filed_at":"2024-10-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.090575+00:00","generated_at":"2026-05-30T20:19:53.981511+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA clinical hold on Kezar's zetomipzomib IND for lupus nephritis after 4 fatal SAEs","bullets":["FDA clinical hold on zetomipzomib IND for lupus nephritis after Kezar voluntarily suspended PALIZADE trial enrollment.","Four Grade 5 (fatal) SAEs in PALIZADE trial (Philippines and Argentina) led to IDMC recommendation for suspension.","Phase 2a PORTOLA trial for autoimmune hepatitis remains active; no Grade 4 or 5 SAEs observed.","FDA to provide official clinical hold letter within 30 days; company investigating fatal cases."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-112969","json":"https://secwatch.observer/filing/0000950170-24-112969.json","markdown":"https://secwatch.observer/filing/0000950170-24-112969.md","text":"https://secwatch.observer/filing/0000950170-24-112969.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645666/000095017024112969/0000950170-24-112969-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645666/000095017024112969/kzr-20241004.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T20:19:53.981511+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"}