Investors Target Unicycive Therapeutics Over Failed FDA Compliance

The complaint filed by Robbins LLP centers on the clinical-stage company's efforts to secure FDA approval for oxylanthanum carbonate, a therapy designed to treat kidney disease. According to the litigation, Unicycive failed to audit its third-party manufacturing vendor adequately, despite previously receiving a Complete Response Letter from regulators in June 2025 that explicitly identified compliance deficiencies at that site. When the company resubmitted its New Drug Application in December 2025, it reportedly lacked a reasonable basis to claim those issues had been resolved.

The consequences of these omissions surfaced on June 30, 2026, when the company revealed that the FDA had issued another rejection citing the same recurring manufacturing failures. The market reaction was swift, as Unicycive shares plummeted 39.1% to close at $4.69. Plaintiffs allege that the company’s repeated positive assurances regarding its regulatory progress were materially misleading, obscuring the significant risk of further delays in the approval process.

Investors who incurred losses during the specified period have until November 2, 2026, to apply for lead plaintiff status. The firm, Robbins LLP, is managing the case on a contingency basis, meaning no upfront costs are required for participants to join the litigation.