Nvidia and TSMC to unveil first domestic wafer for Blackwell chips, Axios reports
SOUTH SAN FRANCISCO - Kezar Life Sciences Inc. (NASDAQ:KZR) announced Thursday it is exploring strategic alternatives to maximize shareholder value after facing regulatory hurdles for its autoimmune hepatitis (AIH) drug candidate. According to InvestingPro data, the company is currently trading below its Fair Value, with analysts maintaining a consensus "Buy" rating and a highest price target of $18.
The clinical-stage biotechnology company reported that the U.S. Food and Drug Administration (FDA) canceled a previously scheduled Type C meeting to discuss a potential registrational trial for zetomipzomib in relapsed and refractory AIH patients. The FDA instead requested a stand-alone study to define the drug’s pharmacokinetics in subjects with significant hepatic impairment before initiating another AIH trial.
This requirement would delay future trials by approximately two years, according to the company. The FDA also mandated 48-hour patient monitoring in a clinical research unit for future zetomipzomib trials, which Kezar believes would hinder patient enrollment.
"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, in a press release statement.
In March 2025, Kezar reported positive data from PORTOLA, which it described as the first successfully completed randomized clinical trial in patients with refractory or relapsed AIH. Final data from this trial will be presented at The Liver Meeting 2025 on November 10 in Washington, DC.
The company has retained TD Cowen to support its strategic review process and will implement a restructuring plan including workforce reduction and other cost-containment measures. Kezar also extended its limited duration shareholder rights plan to protect stockholder interests during this process.
As of September 30, 2025, Kezar reported approximately $90.2 million in cash, cash equivalents and marketable securities. InvestingPro analysis shows the company maintains a healthy current ratio of 7.29, with liquid assets exceeding short-term obligations. However, the company is quickly burning through cash, with negative free cash flow of $64.34 million in the last twelve months.
AIH affects approximately 100,000 individuals in the United States, predominantly women, and currently has no FDA-approved therapeutics. Despite current challenges, InvestingPro data reveals two analysts have recently revised their earnings estimates upward for the upcoming period. Subscribers can access 8 additional exclusive ProTips and comprehensive financial metrics to better evaluate KZR’s potential.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.