On Thursday, Kezar Life Sciences, Inc ( KZR ) decided to terminate the PALIZADE Phase 2b trial in patients with active lupus nephritis (LN) and focus clinical development efforts on zetomipzomib in autoimmune hepatitis (AIH).

Last week, the FDA placed a clinical hold on the company’s zetomipzomib Investigational New Drug (IND) application for LN following a review of emerging safety data, including an assessment of four Grade 5 (fatal or death) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina.

Kezar will unblind the trial and perform a full investigation into all safety events from the study. As of termination, 84 patients were enrolled, and Kezar will report available data from the PALIZADE study later.

The Independent Data Monitoring Committee (IDMC) overseeing the PORTOLA Phase 2a trial of zetomipzomib in patients with AIH recommended that the trial may proceed without modification.

The IDMC examined safety data from all patients enrolled in the trial, including data from patients who completed the blinded treatment period and continued to the open-label extension portion, which includes an additional 24 weeks of treatment.

To date, no Grade 4 or 5 serious adverse events (SAEs) have been observed in the PORTOLA trial.

Kezar has completed enrollment and plans to report topline data from the PORTOLA trial in the first half of 2025.

Earlier on Thursday, Kezar Life Sciences ( KZR ) rejected the previously disclosed unsolicited, non-binding proposal from Concentra Biosciences for cash consideration of $1.10 per share, plus a contingent value right that represents the right to receive 80% of the net proceeds from any out-license or disposition of Kezar’s development programs or intellectual property.

“The proposal would result in an implied equity value for Kezar stockholders that is materially below Kezar’s available liquidity and fails to provide adequate value to reflect the significant potential of zetomipzomib as a therapeutic candidate,” the company said.

Price Action: KZR stock is down 8.48% at $0.82 at last check Thursday.

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