Shareholders who lost money in shares of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) Should Contact Wolf Haldenstein Immediately

Core Viewpoint - A securities class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, specifically regarding misleading statements about the company's FDA compliance and drug candidate prospects [1][2]. Summary by Relevant Sections Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Unicycive securities between March 29, 2024, and June 7, 2025 [1]. - Allegations include false statements regarding the company's readiness to meet FDA manufacturing compliance requirements [2]. - The suit also claims misleading information about the regulatory prospects of the lead drug candidate, oxylanthanum carbonate (OLC), for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3]. Key Events - In September 2024, Unicycive submitted its New Drug Application (NDA) for OLC to the FDA [7]. - On June 10, 2025, the company disclosed that the FDA found deficiencies in cGMP compliance at a third-party manufacturing subcontractor, leading to a stock drop of 40.9% to $5.32 [7]. - On June 30, 2025, the FDA issued a Complete Response Letter (CRL) rejecting the OLC NDA due to the same cGMP issues, causing the stock to fall another 29.9% to $4.77 [7]. - Investors must seek lead plaintiff appointment by October 14, 2025 [7].