Kezar Life Sciences Shares Surge Amid FDA Break and Restructuring Plan

Kezar Life Sciences shares surged after the company announced it would explore strategic options and cut jobs following a FDA setback. The biotech firm's stock rose 40.41% to $5.855 in pre-market trading. The FDA had previously placed a partial clinical hold on the company's Zetomipzomib trial in autoimmune hepatitis.

Kezar Life Sciences Inc. (NASDAQ: KZR) saw its stock surge by 40.41% to $5.855 in pre-market trading on September 12, 2025, following the announcement that the company would explore strategic alternatives and implement workforce reductions. The move comes in the wake of a significant regulatory setback from the U.S. Food and Drug Administration (FDA), which canceled a scheduled Type C meeting to discuss a potential registrational trial for the company's autoimmune hepatitis (AIH) drug candidate, zetomipzomib.

The FDA's decision to cancel the meeting and request a stand-alone study to define the drug’s pharmacokinetics in subjects with significant hepatic impairment has delayed future trials by approximately two years. Additionally, the FDA mandated 48-hour patient monitoring in a clinical research unit for future trials, which Kezar believes would hinder patient enrollment.

Chris Kirk, CEO of Kezar Life Sciences, expressed disappointment with the FDA's decision, stating, "We are incredibly disappointed with the unusual decision by the FDA to cancel our Type C meeting, which we had hoped would allow us to align on key clinical trial parameters for a potentially registration-enabling study of zetomipzomib in patients with AIH."

Kezar has retained TD Cowen to support its strategic review process and will implement a restructuring plan including workforce reduction and other cost-containment measures. As of September 30, 2025, the company reported approximately $90.2 million in cash, cash equivalents, and marketable securities, with a healthy current ratio of 7.29 and negative free cash flow of $64.34 million in the last twelve months.

The company has extended its limited duration shareholder rights plan to protect stockholder interests during this process. The extended rights plan is intended to protect the interests of the Company and its stockholders, help ensure that all interested parties have the opportunity to participate fairly in the strategic review process, and provide the Board time to make informed decisions.

Kezar Life Sciences is a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. The company is exploring strategic alternatives to maximize shareholder value following the FDA setback, which includes a workforce reduction and other cost-containment measures.