Kezar Life Sciences faces FDA delays for AIH drug trials, implements restructuring, and explores strategic alternatives amid potential acquisition interest.
Kezar announced on Thursday that it was unable to align with the FDA on a potential registrational clinical trial of Zetomipzomib in patients with relapsed and refractory autoimmune hepatitis.
Kezar Life Sciences halted its PALIZADE Phase 2b lupus nephritis trial due to fatal adverse events. Meanwhile, its PORTOLA Phase 2a autoimmune hepatitis trial progresses, with topline data expected in 2025. Kezar also rejected a buyout proposal from Concentra Biosciences.
Kezar Life Sciences' zetomipzomib drug for lupus nephritis has been placed on clinical hold by the FDA following serious safety concerns. The company continues its autoimmune hepatitis trials while reallocating resources from other programs.
Kezar Life Sciences announced it has stopped enrollment in its phase 1 solid tumor drug study and will focus on developing zetomipzomib for autoimmune diseases.
