Kezar Life Sciences secured a U.S. Food and Drug Administration Type C meeting for the first quarter of 2026 to discuss the development of its selective immunoproteasome inhibitor, zetomipzomib, in patients with autoimmune hepatitis (AIH).
The meeting will review a proposed global, randomized Phase 2b study design, including patient selection, endpoints, and risk‑mitigation strategies. Kezar submitted pharmacokinetic and hepatic safety data from earlier trials, along with an updated plan to address the FDA’s earlier requirement for 48‑hour inpatient monitoring.
This regulatory step follows a series of setbacks, including a cancelled Type C meeting and clinical holds on related trials. Successful alignment with the FDA could clear a pathway for the Phase 2b study and future approvals, potentially accelerating the drug’s development timeline.
Kezar is concurrently exploring strategic alternatives and has retained TD Cowen to evaluate options. The company’s financial profile—negative earnings and significant cash burn—has heightened the urgency of these alternatives, underscoring the strategic importance of the FDA meeting.
CEO Chris Kirk emphasized that FDA alignment would unlock value for shareholders while acknowledging the need to navigate ongoing regulatory and financial headwinds.
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