
Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 29, 2024, to June 27, 2025 [1][6]. Company Overview - Unicycive is a clinical-stage biotechnology company focused on developing therapies for unmet medical needs, including oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [4]. Legal Proceedings - The lawsuit seeks to recover damages for investors who purchased Unicycive securities during the Class Period, alleging that the company made materially false and misleading statements regarding its business and compliance policies [1][6]. - Investors have until October 14, 2025, to request appointment as Lead Plaintiff in the class action [2]. Regulatory Issues - Throughout the Class Period, Unicycive's management allegedly overstated the company's readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of the OLC New Drug Application (NDA) [6]. - On June 10, 2025, Unicycive disclosed deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a significant drop in stock price by $3.68 per share (40.89%) [7]. - Following this, on June 30, 2025, the FDA issued a Complete Response Letter for the OLC NDA, further impacting the stock price, which fell by $2.03 per share (29.85%) [8].