Nvidia and TSMC to unveil first domestic wafer for Blackwell chips, Axios reports
Investing.com - William Blair downgraded Kezar Life Sciences (NASDAQ:KZR) from Outperform to Market Perform following regulatory challenges with the company’s lead drug candidate. The company, currently valued at $30.5 million and trading nearly 50% below its year-ago levels, maintains a strong balance sheet with more cash than debt according to InvestingPro data.
The downgrade comes after Kezar announced on Thursday that the U.S. Food and Drug Administration (FDA) canceled a scheduled Type C meeting intended to discuss pivotal trial design for zetomipzomib in autoimmune hepatitis (AIH).
Instead of proceeding with the planned discussion, the FDA proposed that Kezar first conduct a stand-alone trial in patients with significant hepatic impairment, which would delay any future AIH studies by approximately two years.
Due to resource constraints, Kezar management has initiated a process to explore strategic alternatives rather than pursuing the FDA’s proposed path forward.
The regulatory setback occurred despite positive Phase II trial results in AIH and what William Blair described as a tolerable safety profile in patients not on background high-dose steroids, particularly notable after the FDA’s Division of Hepatology and Nutrition had lifted a prior partial clinical hold in July.
In other recent news, Kezar Life Sciences announced it is exploring strategic alternatives following a setback with the U.S. Food and Drug Administration (FDA) concerning its lead drug candidate, zetomipzomib. The FDA canceled a scheduled Type C meeting and requested a stand-alone study to assess the drug’s pharmacokinetics in patients with significant hepatic impairment before proceeding with further trials for autoimmune hepatitis (AIH). This development has prompted the company to seek new strategies to maximize shareholder value. In response to these challenges, Jefferies downgraded Kezar Life Sciences from Buy to Hold, reducing the price target from $18.00 to $7.00. The downgrade reflects a decrease in the estimated probability of success for zetomipzomib from 25% to 10%. Despite these hurdles, Kezar Life Sciences’ stock saw a significant increase as the company announced its plans to explore strategic options. This series of events underscores the company’s ongoing efforts to navigate regulatory challenges and explore avenues for growth.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.