New York – September 12, 2026 -- Rosen Law Firm has filed a securities class action against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) covering purchasers of the company's securities between December 29, 2025 and June 29, 2026.
Lawsuit alleges Unicycive never audited its manufacturing vendor's facility
The complaint claims Unicycive had not inspected its third-party manufacturing vendor's plant or verified compliance with current good manufacturing practices, leaving the company without a reasonable basis to assert the vendor had fixed deficiencies previously cited by the U.S. Food and Drug Administration.
Complaint says FDA approval of lead drug candidate OLC faced undisclosed delay risk
According to the filing, an undisclosed risk existed that the FDA would demand additional information about the vendor's manufacturing practices, making regulatory approval of oxylanthanum carbonate (OLC) reasonably likely to be delayed. The lawsuit alleges that as a result, Unicycive's public statements about its business, operations, and prospects during the Class Period were materially misleading or lacked a reasonable basis.
Lead plaintiff deadline set for November 2, 2026
Investors who purchased Unicycive securities during the Class Period may move the court to serve as lead plaintiff no later than November 2, 2026. A lead plaintiff acts as a representative party directing the litigation on behalf of other class members, though the ability to share in any future recovery does not depend on serving in that role.
No class has been certified yet
Until a class is certified, investors are not represented by counsel unless they retain one individually. Absent class members may also take no action and remain part of the case without formally joining.