Kezar Life Sciences Announces Regulatory Update on Zetomipzomib Program in Autoimmune Hepatitis

About this update from Kezar Life Sciences, Inc.

SOUTH SAN FRANCISCO, Calif., January 09, 2026--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that the Food and Drug Administration (FDA) Division of Hepatology and Nutrition has granted Kezar a Type C meeting for the first quarter to discuss the development of zetomipzomib, a novel, selective inhibitor of the immunoproteasome, in patients with autoimmune hepatitis (AIH). The Type C meeting will involve review of a potential global, randomized Phase 2b clinical study of zetomipzomib in patients with relapsed and refractory AIH. As part of the briefing package submitted to the FDA, Kezar submitted pharmacokinetic and hepatic safety data analyses from previously conducted clinical trials to support a proposal for parallel AIH and hepatic impairment studies. Kezar also submitted additional safety data and an updated risk-mitigation plan aimed to modify the previous requirement issued from the FDA to require 48-hour in-unit patient monitoring in future AIH studies. "We appreciate the opportunity to collaborate with the FDA on key clinical trial parameters for a well-powered study of zetomipzomib in patients with AIH, a population with significant unmet medical need and currently without FDA-approved therapies," said Chris Kirk, PhD, CEO of Kezar Life Sciences. "The additional safety and pharmacokinetic data analysis performed in response to prior FDA feedback further support our belief that zetomipzomib has the potential to change the treatment landscape in this serious disease. Furthermore, achieving alignment with the FDA on endpoints and trial conduct would provide a clear development pathway for this novel therapy and potentially unlock value for our shareholders as we continue to evaluate strategic alternatives." As previously disclosed, Kezar has retained TD Cowen to support the company with its ongoing strategic review process focusing on maximizing shareholder value, and which included a significant workforce reduction and other cost-containment and cash conservation measures. About Kezar Life Sciences Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, ...

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