Unicycive Therapeutics Faces Class Action Over Manufacturing Deficiencies

SAN DIEGO, Sept. 8, 2026 /CourierPR/ -- Unicycive Therapeutics, Inc., a clinical-stage biotechnology firm, faces a class action lawsuit following a significant drop in its stock price. The lawsuit, filed by Robbins LLP, a shareholder rights law firm, alleges that Unicycive failed to disclose key information to investors regarding its manufacturing processes and regulatory compliance.

Unicycive, based on its New Drug Application (NDA) for oxylanthanum carbonate (OLC), a potential therapy for kidney diseases, submitted its application to the U.S. Food and Drug Administration (FDA) in September 2024. The FDA accepted the NDA in November 2024. However, on June 29, 2025, the FDA issued a Complete Response Letter (CRL) citing deficiencies at a third-party manufacturing vendor. In response, Unicycive held a Type A meeting with the FDA in October 2025. Despite this, the FDA resubmitted the NDA in December 2025, only to receive the same CRL in June 2026, reiterating the same manufacturing deficiencies.

According to the complaint, during the class period from December 29, 2025, to June 29, 2026, Unicycive allegedly failed to inform investors that it had not inspected the manufacturing vendor's facility or audited its compliance with current good manufacturing practices. This omission, plaintiffs argue, created an undisclosed risk that the FDA would require additional information about the vendor's facility's manufacturing practices, thereby delaying the regulatory approval of OLC.

On June 30, 2026, Unicycive's stock price plummeted by 39.1%, closing at $4.69 per share, after the company disclosed that the FDA had issued the same CRL regarding the resubmitted NDA. The unusually heavy trading volume and the sudden drop in stock price were seen as direct consequences of the regulatory setback.

Robbins LLP, a recognized leader in shareholder rights litigation, has advised investors who purchased or otherwise acquired Unicycive securities during the class period to contact the firm before the November 2, 2026, lead plaintiff deadline. The lawsuit seeks to represent investors who suffered losses during the period and aims to hold Unicycive accountable for allegedly misleading statements regarding its manufacturing processes and regulatory compliance.

The press release highlights the importance of transparency and compliance in the biotechnology sector, where regulatory hurdles can significantly impact a company's market performance and investor confidence. As the litigation progresses, it remains to be seen how this will affect Unicycive's ongoing efforts to develop and commercialize therapies for kidney diseases.