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What regulatory action will EMA take on Kezar Life Sciences' Zetomipzomib Lupus Nephritis trial by March 31, 2025?
2
Resolution / Starting Odds
Clinical hold • 25%
No action • 25%
Request for additional data • 25%
Other • 25%
Official announcements from EMA or Kezar Life Sciences
Story
Kezar Life Sciences Voluntarily Halts Enrollment in Zetomipzomib Lupus Nephritis Trial
Sep 30, 2024, 12:24 PM
Kezar Life Sciences has announced the voluntary cessation of enrollment and dosing in its Phase 2b PALIZADE trial of Zetomipzomib for active lupus nephritis patients. This decision follows a recent review of emerging safety data by the Independent Data Monitoring Committee (IDMC), which included an assessment of four Grade 5 (fatal) serious adverse events (SAEs). The company is notifying the FDA and EMA but has not yet received a clinical hold letter.
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