Kezar Life Sciences, Inc. (NASDAQ:KZR) announced regulatory updates and began exploring strategic alternatives.
The company has retained TD Cowen to support it with the strategic review process.
Kezar has been unable to align with the Food and Drug Administration (FDA) on a potential registrational clinical trial of zetomipzomib for relapsed and refractory autoimmune hepatitis (AIH).
The FDA Division of Hepatology and Nutrition canceled a Type C meeting scheduled in the fourth quarter.
Autoimmune hepatitis is a rare, chronic disease that can lead to cirrhosis, liver failure, and hepatocellular carcinoma.
In the United States, AIH affects approximately 100,000 individuals, predominantly women.
Also Read: FDA Lifts Pause On Kezar’s Liver Drug Trial—Next Stop Lupus Study
Kezar submitted a comprehensive report to the FDA that integrated safety, efficacy, and pharmacology data across more than 300 patients and healthy volunteers enrolled in zetomipzomib clinical trials, as well as a risk mitigation plan for outpatient monitoring for future trials that was modeled after approved injectable therapeutics.
In their written response, the FDA requested that 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.
Kezar informed the FDA that they would exclude AIH patients with significant hepatic impairment in the proposed registration-enabling study.
The interim study required by the FDA would delay future trials of zetomipzomib in AIH by approximately 2 years.
In addition, the FDA has required future clinical trials of zetomipzomib to include 48-hour patient monitoring in a clinical research unit, which would likely hinder patient enrollment and participation.
“We are incredibly disappointed with the unusual decision by the FDA to cancel our Type C meeting…” said Chris Kirk, CEO of Kezar Life Sciences.
The company will implement a restructuring plan, including a workforce reduction and other cost-containment and cash conservation measures.
As of Sept. 30, 2025, the company’s cash, cash equivalents, and marketable securities totaled approximately $90.2 million.
William Blair downgraded Kezar shares to Market Perform. Analyst Matt Phipps said a higher stock price reflects a potential takeout value for the company based on cash balance alone.
William Blair notes a prior unsolicited acquisition proposal from Tang Capital in 2024, which valued the company at roughly 50% of Kezar's cash balance at the time.
KZR Price Action: Kezar Life Sciences shares were up 49.25% at $6.22 at the time of publication on Friday, according to Benzinga Pro data.
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