Unicycive Therapeutics Faces Securities Class Action Lawsuit
News related to:Unicycive Therapeutics Inc · 2 min read
Unicycive Therapeutics, a biotech firm trading on the NASDAQ under the ticker UNCY, is facing a securities class action lawsuit. The legal action, initiated by Faruqi & Faruqi, LLP, a leading national securities law firm, alleges that the company and its executives misled investors regarding manufacturing compliance and regulatory risks.
According to the lawsuit, Unicycive Therapeutics failed to disclose critical information about its third-party manufacturing vendor's facility, which was not inspected or audited for compliance with current good manufacturing practices (cGMP). This oversight, the lawsuit claims, left the company without a reasonable basis to believe that the vendor had resolved deficiencies cited by the U.S. Food and Drug Administration (FDA).
On June 30, 2026, Unicycive disclosed that the FDA had issued a second Complete Response Letter (CRL) regarding the company's resubmitted New Drug Application for its kidney disease therapy, oxylanthanum. The CRL identified the same third-party manufacturing deficiencies that were previously cited in June 2025. This news sent Unicycive's stock price plummeting by $3.01, or 39.1%, to close at $4.69 per share.
Faruqi & Faruqi, LLP, is now reminding investors who purchased or acquired Unicycive securities between December 29, 2025, and June 29, 2026, of the November 2, 2026, deadline to seek the role of lead plaintiff in the federal securities class action. The firm encourages investors who suffered financial losses to contact partner James (Josh) Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310) for more information.
The lawsuit alleges that the company and its executives violated federal securities laws by making false and misleading statements and failing to disclose the risks associated with the third-party manufacturing vendor. Specifically, the lawsuit claims that the company did not have a reasonable basis to believe that the vendor had resolved the FDA's cited deficiencies, and that there was an undisclosed risk that the FDA would require additional information about the vendor's facility's manufacturing practices. As a result, the regulatory approval of oxylanthanum was reasonably likely to be delayed, the lawsuit asserts.
Faruqi & Faruqi, LLP, has a history of representing investors in securities litigation and has recovered hundreds of millions of dollars for shareholders. The firm's partner, Josh Wilson, is urging investors to contact the firm to discuss their legal rights and potential claims. Investors are reminded that they can also seek appointment as lead plaintiff by filing a motion with the court by the November 2, 2026, deadline.
The lawsuit is part of a broader investigation into Unicycive Therapeutics' conduct and its compliance with regulatory requirements. The firm is also encouraging anyone with information regarding the company's conduct to contact them, including whistleblowers, former employees, and shareholders.