Workflow
Pomerantz Law Firm Announces the Filing of a Class Action Against Unicycive Therapeutics, Inc. and Certain Officers - UNCY
UnicyciveUnicycive(US:UNCY) Prnewswireยท2025-08-27 14:00

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of federal securities laws during the Class Period from March 29, 2024, to June 27, 2025, related to misleading statements about the company's readiness for FDA compliance and the prospects of its New Drug Application for oxylanthanum carbonate [1][5]. Group 1: Lawsuit Details - The lawsuit is filed in the United States District Court Northern District of California, seeking damages for all persons and entities that purchased Unicycive securities during the Class Period [1]. - Investors have until October 14, 2025, to request to be appointed as Lead Plaintiff for the class [2]. Group 2: 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 patients on dialysis [3]. Group 3: Allegations Against Defendants - Defendants allegedly made materially false and misleading statements regarding the company's business and compliance policies, overstating Unicycive's readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of the OLC NDA [5]. - On June 10, 2025, Unicycive disclosed deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a significant stock price drop of 40.89% [6]. - Following the issuance of a Complete Response Letter (CRL) from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock price fell an additional 29.85% [7].