Workflow
OLC (for treating hyperphosphatemia in patients with CKD on dialysis)
icon
Search documents
SHAREHOLDER ACTION REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Unicycive Therapeutics
Prnewswireยท 2025-08-21 15:05
Core Viewpoint - The complaint against Unicycive alleges violations of federal securities laws due to false or misleading statements regarding the company's compliance with FDA manufacturing requirements and the regulatory prospects of its OLC NDA [2]. Group 1: Company Performance and Regulatory Issues - On June 10, 2025, Unicycive announced that the FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a significant stock price drop of $3.68 per share, or 40.89%, closing at $5.32 [3]. - On June 30, 2025, Unicycive disclosed that the FDA issued a Complete Response Letter for the OLC NDA, citing the same cGMP deficiencies, resulting in a further stock price decline of $2.03 per share, or 29.85%, closing at $4.77 [4]. Group 2: Legal Proceedings - The lead plaintiff in the class action lawsuit is the investor with the largest financial interest in the relief sought, who will oversee the litigation on behalf of the class [5]. - Any member of the putative class can move to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [5]. Group 3: Whistleblower Information - The law firm Faruqi & Faruqi encourages individuals with information regarding Unicycive's conduct, including whistleblowers and former employees, to come forward [6].