On 17 October 2025, Kezar Life Sciences announced today that the FDA’s Division of Hepatology and Nutrition cancelled a previously scheduled Type C meeting and issued a request for a stand‑alone pharmacokinetic study in subjects with hepatic impairment before any new AIH trial could begin. The FDA also mandated 48‑hour inpatient monitoring for future studies, a requirement that would significantly increase trial costs and enrollment complexity, potentially delaying the program by approximately two years.
The regulatory setback forces Kezar to reassess its AIH development pathway and consider alternative strategies. The company has therefore begun a formal review of strategic alternatives, including a restructuring plan that will reduce workforce and implement cost‑containment measures. This shift signals a potential pivot away from the current clinical trajectory and underscores the financial and operational risks associated with the program’s delayed timeline.
Kezar’s cash, cash equivalents and marketable securities stood at roughly $90.2 million as of 30 September 2025, a figure that will be strained by the additional regulatory requirements and the planned workforce reductions. The board has also extended its limited‑duration stockholder rights plan to protect the interests of shareholders during the strategic review. These actions collectively highlight the company’s immediate need to preserve capital while navigating the new regulatory landscape.
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