The complaint filed against the San Diego-based clinical-stage company focuses on the period between December 29, 2025, and June 29, 2026. Investors allege that Unicycive lacked a reasonable basis to claim it had resolved manufacturing deficiencies cited by the FDA in relation to its kidney disease therapy, oxylanthanum carbonate. While the company resubmitted its New Drug Application in December 2025, plaintiffs contend that leadership failed to conduct necessary audits of their third-party vendor, masking risks that regulatory approval would likely be delayed.
Unicycive Therapeutics Faces Class Action Over FDA Manufacturing Oversight
A federal class action lawsuit now targets Unicycive Therapeutics after the biotechnology firm allegedly misled investors regarding the status of a critical third-party manufacturing facility. The litigation centers on claims that the company failed to verify compliance with FDA standards, leading to a significant stock price collapse.
These concerns materialized on June 30, 2026, when the company revealed that the FDA had issued a second Complete Response Letter citing the same manufacturing issues identified a year prior. Following the announcement, Unicycive shares plummeted by 39.1%, closing at $4.69 per share. The law firm Robbins LLP is now seeking lead plaintiffs for the action, with a court-imposed deadline of November 2, 2026. Participation in the suit carries no upfront costs for investors, as the firm operates on a contingency fee basis.
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