---
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"
generated_at: "2026-05-30T20:19:53.981511+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA clinical hold on Kezar's zetomipzomib IND for lupus nephritis after 4 fatal SAEs

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-112969
- JSON: https://secwatch.observer/filing/0000950170-24-112969.json
- Plain text: https://secwatch.observer/filing/0000950170-24-112969.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.