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Investing.com -- Kezar Life Sciences, Inc. (NASDAQ:KZR) stock gained 40% despite the clinical-stage biotechnology company announcing plans to explore strategic alternatives following a regulatory setback for its lead drug candidate.
The company revealed it has been unable to align with the Food and Drug Administration (FDA) on a potential registrational clinical trial of zetomipzomib in patients with relapsed and refractory autoimmune hepatitis (AIH). The FDA canceled a previously scheduled Type C meeting and requested Kezar conduct a stand-alone study to define the pharmacokinetics of zetomipzomib in subjects with significant hepatic impairment before initiating another clinical trial in AIH.
This regulatory hurdle would delay future trials by approximately 2 years, according to the company. Additionally, the FDA has mandated 48-hour patient monitoring in a clinical research unit for future trials, which Kezar believes would hinder patient enrollment and participation.
In response to these challenges, Kezar has retained TD Cowen to support a strategic review process aimed at maximizing shareholder value. The company will implement a restructuring plan including workforce reductions and other cost-containment measures while retaining employees essential for supporting value creation.
"We are incredibly disappointed with the unusual decision by the FDA to cancel our Type C meeting, which we had hoped would allow us to align on key clinical trial parameters for a potentially registration-enabling 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 company reported that as of September 30, 2025, its cash, cash equivalents and marketable securities totaled approximately $90.2 million. Kezar’s Board of Directors has also extended its limited duration stockholder rights plan to protect the integrity of the strategic review process.
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