Kezar Life Sciences(US:KZR) Businesswire·2026-01-09 11:01Core Viewpoint - Kezar Life Sciences has received a Type C meeting from the FDA to discuss the development of zetomipzomib for autoimmune hepatitis, indicating progress in its clinical development and potential for addressing unmet medical needs in this area [1][2][3] Group 1: Company Overview - Kezar Life Sciences is a clinical-stage biotechnology company focused on developing small molecule therapeutics for immune-mediated diseases [4] - Zetomipzomib is a selective immunoproteasome inhibitor being evaluated for autoimmune hepatitis and has potential applications in multiple chronic immune-mediated diseases [5] Group 2: Clinical Development - The Type C meeting will review a proposed global, randomized Phase 2b clinical study of zetomipzomib in patients with relapsed and refractory autoimmune hepatitis [2] - Kezar submitted pharmacokinetic and hepatic safety data from previous trials to support its proposal for parallel studies in autoimmune hepatitis and hepatic impairment [2] Group 3: Market Need - Autoimmune hepatitis is a rare chronic disease affecting approximately 100,000 individuals in the U.S., with a significant unmet medical need for effective treatments [6] - Current standard treatments involve chronic immunosuppressive therapies that can lead to severe side effects, highlighting the need for alternatives that minimize or eliminate the use of corticosteroids [6] Group 4: Strategic Initiatives - The company is undergoing a strategic review process to maximize shareholder value, which includes workforce reductions and cost-containment measures [3] - Kezar has engaged TD Cowen to assist in this strategic review, indicating a focus on enhancing shareholder returns [3]