Kezar Life Sciences' Zetomipzomib IND For Lupus Nephritis Placed On Clinical Hold By FDA; Stock Down

(RTTNews) - Kezar Life Sciences, Inc. (KZR) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) application for zetomipzomib, intended for treating lupus nephritis (LN).

The decision follows Kezar's voluntary suspension of enrollment and dosing in the Phase 2b PALIZADE clinical trial for active LN, based on the recommendation of the trial's Independent Data Monitoring Committee (IDMC).

The IDMC made this recommendation after reviewing emerging safety data, which included four Grade 5 (fatal) serious adverse events (SAEs) reported among participants in the Philippines and Argentina. The FDA has informed Kezar that an official clinical hold letter will be issued within 30 days.

KZR closed Friday's regular trading at $0.80 down $0.03 or 3.40%. In the after-hours trading, the stock further dropped $0.03 or 3.45%.

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