Kezar Life Sciences Faces Existential Crisis After Clinical Trial Setback
31.10.2025 - 09:06:04Regulatory Demands Trigger Corporate Overhaul
The future of Kezar Life Sciences hangs in the balance following a devastating regulatory development that has forced the biotechnology firm into emergency restructuring. With its lead drug candidate facing significant delays, the company is implementing drastic survival measures.
On October 16, Kezar received crushing news from the U.S. Food and Drug Administration. The regulatory agency unexpectedly terminated discussions regarding the approval pathway for flagship drug Zetomipzomib, instead demanding an additional study focused on patients with liver impairment. This new requirement is projected to delay the entire development program by approximately two years.
The immediate consequences have been severe:
– The company must execute a complete strategic repositioning
Read more...


