Unicycive Therapeutics Faces Legal Scrutiny Over Vendor Inspection Allegations

Unicycive Therapeutics, Inc., a clinical-stage biotechnology company focused on developing therapies for kidney diseases, is facing legal scrutiny following allegations that it failed to properly inspect its third-party vendor's manufacturing facility. The investigation, conducted by Robbins LLP, a law firm specializing in shareholder rights litigation, centers on the company's handling of FDA inspections and compliance issues.

According to the complaint, Unicycive submitted a New Drug Application (NDA) for its kidney disease therapy, oxylanthanum carbonate (OLC), to the FDA in September 2024. The application was accepted in November 2024. In June 2025, the FDA issued a Complete Response Letter (CRL) citing deficiencies at a third-party manufacturing vendor. Following this, Unicycive held a Type A meeting with the FDA in October 2025 to discuss the single deficiency related to the vendor's compliance status. After receiving official meeting minutes and engaging with the vendor, Unicycive resubmitted the NDA in December 2025.

The complaint alleges that during the class period, which spans from December 29, 2025, to June 29, 2026, Unicycive failed to disclose to investors several critical pieces of information. These include:

- The company had not inspected its third-party manufacturing vendor's facility or otherwise audited the facility's compliance with current good manufacturing practices. - There was no reasonable basis to believe that the vendor had resolved the FDA's cited deficiencies. - An undisclosed risk existed that the FDA would require additional information about the vendor's facility's manufacturing practices. - The regulatory approval of OLC was reasonably likely to be delayed as a result.

These omissions, according to the complaint, rendered the company's positive statements about its business, operations, and prospects materially misleading and lacking a reasonable basis. As a result, investors who purchased or otherwise acquired Unicycive Therapeutics, Inc. securities during the class period may be eligible to participate in a class action lawsuit.

The lawsuit seeks to represent investors who suffered significant losses during the class period. Investors who wish to lead the class action must contact Robbins LLP before the November 2, 2026, lead plaintiff deadline. Robbins LLP, a recognized leader in shareholder rights litigation, represents investors in securities fraud and shareholder derivative litigation.

The press release highlights the importance of transparency and compliance in the biotechnology sector, particularly when dealing with regulatory bodies like the FDA. Unicycive's failure to properly inspect its vendor's facility and disclose relevant information to investors has raised concerns about the company's management and communication practices.