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

Kezar Life Sciences, Inc.

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.

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