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UNCY Investors: If you Lost Significant Money in UNCY Contact Robbins LLP for Information About the Securities Fraud Class Action Against Unicycive Therapeutics, Inc.
UnicyciveUnicycive(US:UNCY) Prnewswireยท2025-09-06 02:49

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for allegedly misleading investors regarding the readiness of its drug application and compliance with FDA manufacturing requirements [1][2]. Group 1: Allegations and Company Background - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for unmet medical needs in the U.S. [1] - The lawsuit claims that Unicycive misrepresented the prospects of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) intended for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2]. - The complaint alleges that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [2]. Group 2: Recent Developments - On June 10, 2025, Unicycive disclosed that the FDA identified deficiencies in current good manufacturing practice (cGMP) compliance at a third-party manufacturing vendor, which impacted discussions regarding the drug label [3]. - Following this announcement, Unicycive's stock price dropped over 40% [3]. - On June 30, 2025, the FDA issued a Complete Response Letter for the OLC NDA, further citing the cGMP deficiencies, leading to an additional stock price decline of nearly 30%, closing at $4.77 per share [3]. Group 3: Class Action Participation - Shareholders may be eligible to participate in the class action against Unicycive and can contact Robbins LLP to serve as lead plaintiff before the October 14, 2025 deadline [4]. - Participation in the case is not required to be eligible for recovery, allowing shareholders to remain absent class members if they choose [4]. Group 4: Firm Background - Robbins LLP is recognized for its focus on shareholder rights litigation, helping shareholders recover losses and improve corporate governance since 2002 [5].