What's Happening?
Kezar Life Sciences is laying off approximately 70% of its workforce following the FDA's cancellation of a meeting regarding its autoimmune hepatitis drug, zetomipzomib. The company had planned to discuss
a pivotal trial design for the drug, but the FDA recommended a stand-alone trial instead, potentially delaying development by two years. This decision comes after previous clinical holds due to patient deaths in trials for lupus, leading to the discontinuation of that program.
Why It's Important?
The layoffs at Kezar highlight the challenges biotech companies face when navigating regulatory hurdles. The FDA's decision to cancel the meeting and suggest a different trial design could significantly impact Kezar's timeline and financial stability. This situation underscores the importance of strategic planning and resource management in the biotech industry, especially when dealing with complex drug development processes.
What's Next?
Kezar is exploring strategic alternatives to manage resource constraints and continue development of zetomipzomib for autoimmune hepatitis. The company aims to align with the FDA on the design of future clinical trials, while also presenting positive Phase II trial results. Stakeholders will be watching closely to see how Kezar navigates these challenges and whether it can secure the necessary approvals to advance its drug pipeline.
