Kezar Life Sciences Begins Strategic Review After FDA Disagreement on Liver Drug Plans

Kezar Life Sciences announced a strategic review and regulatory updates after the FDA rejected its plans to conduct a registrational clinical trial of zetomipzomib for autoimmune hepatitis, according to a Morningstar report https://www.morningstar.com/news/business-wire/20251016630140/kezar-life-sciences-announces-regulatory-update-on-zetomipzomib-program-in-autoimmune-hepatitis-and-plans-to-explore-strategic-alternatives.

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company focused on developing novel small molecule therapeutics for immune-mediated diseases, has announced significant regulatory updates and initiated a strategic review process following the FDA's rejection of its plans to conduct a registrational clinical trial of zetomipzomib for autoimmune hepatitis (AIH).

The FDA requested a stand-alone study to define the pharmacokinetics of zetomipzomib in subjects with significant hepatic impairment, which would delay future trials of zetomipzomib in AIH by approximately 2 years. The FDA also required 48-hour patient monitoring in a clinical research unit for future trials, which could hinder patient enrollment and participation. Kezar Life Sciences expressed disappointment with the FDA's decision, noting that they had provided the agency with pharmacokinetic data and a robust risk mitigation plan for future clinical trials. However, the company lacks the resources to extend the development timeline and questions the technical feasibility, medical need, and patient burden of the required in-unit monitoring program.

In response to these regulatory challenges, Kezar Life Sciences has initiated a strategic review process to explore a full range of alternatives focused on maximizing shareholder value. As part of this process, the company plans to implement a restructuring plan, including a workforce reduction and other cost-containment and cash conservation measures. The company's cash balance, as of September 30, 2025, is approximately $90.2 million.

The Board of Directors has also adopted an amendment to extend the duration of the company's limited duration stockholder rights plan, effective immediately. This extension is intended to protect the interests of the company and its stockholders, ensure fair participation in the strategic review process, and provide the Board time to make informed decisions. The rights plan does not prevent the Board from engaging with parties or accepting an acquisition proposal if it is in the best interests of Kezar and its stockholders.

Kezar Life Sciences remains committed to patient safety and the development of zetomipzomib as a potential first approved agent in AIH, a population with significant unmet medical needs. However, the company acknowledges the challenges posed by the FDA's requirements and the need to explore strategic alternatives to maximize shareholder value.