Kezar Life Sciences (NASDAQ:KZR) announced Friday that the FDA has granted a formal Type C meeting for the first quarter of 2026, a move that could revive the clinical path for its lead asset, zetomipzomib, following months of regulatory uncertainty.
The meeting will focus on the design of a global Phase 2b study for patients with autoimmune hepatitis (AIH), a rare and serious liver condition with no currently approved FDA therapies.
Kezar is seeking to overturn a previous FDA mandate that required 48-hour in-unit monitoring for all patients—a requirement the company previously argued was a "patient burden" that threatened the feasibility of the trial.
To support its case, Kezar has submitted new hepatic safety and pharmacokinetic (PK) data intended to show that zetomipzomib can be safely administered without the intensive monitoring requirement.
The company also proposed parallel studies to address the FDA’s earlier concerns regarding patients with significant liver impairment.
The regulatory update comes at a transformative time for the San Francisco-based biotech.
In late 2025, Kezar implemented a drastic restructuring plan, slashing its workforce by 70% (roughly 31 positions) to conserve cash and focus solely on maximizing the value of zetomipzomib.
The company has retained investment bank TD Cowen to explore strategic options, which analysts suggest could range from a licensing deal or merger to a total sale of the company.
Autoimmune hepatitis represents a significant commercial opportunity; current standards of care rely heavily on long-term steroid use, which often leads to severe side effects like osteoporosis and diabetes.
Zetomipzomib, a selective immunoproteasome inhibitor, is designed to modulate the immune system without the broad-spectrum toxicity of traditional immunosuppressants.
With approximately $90 million in cash as of its last reporting, the outcome of the Q1 FDA meeting will likely determine whether Kezar proceeds as an independent entity or accelerates its pursuit of a buyer.