#United States #California #Class Action #Pomerantz LLP #Unicycive

Pomerantz Law Firm Launches Class Action Against Unicycive Therapeutics

On September 23, 2025, Pomerantz LLP announced it has filed a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and certain executives of the company. The suit, recorded under docket number 25-cv-06923, is filed in the United States District Court for the Northern District of California. It seeks to represent all individuals and entities, not including the defendants, that purchased or acquired Unicycive securities during the period from March 29, 2024, to June 27, 2025.

Allegations

The central claims against Unicycive and its executives revolve around violations of federal securities laws and misleading public statements concerning the company’s operations and regulatory compliance. Specifically, the lawsuit aims to address alleged discrepancies in the company’s reporting of its new drug application (NDA) for oxylanthanum carbonate (OLC), a phosphate binder meant for treating patients with chronic kidney disease (CKD).

Unicycive had informed investors about its efforts toward submitting an application to the U.S. Food and Drug Administration (FDA) for the OLC, highlighting the company's preparedness to meet required manufacturing compliance. The complaint, however, contends that these statements were materially false, asserting that Unicycive’s actual readiness was overstated. It claims that the management failed to disclose significant challenges regarding FDA compliance and thus misled investors about the prospects of the NDA.

Class Period and Damages

Those who invested in Unicycive securities during the specified Class Period and who may have suffered financial losses are eligible to engage with the lawsuit. They have until October 14, 2025, to request to be appointed as Lead Plaintiff. This means that they can take a more active role in the litigation process. Investors seeking further information can access the formal complaint on the Pomerantz Law Firm’s website or reach out directly to their inquiry department for assistance.

Recent Developments

The lawsuit gained traction following a series of unsettling announcements from Unicycive around mid-2025. On June 10, the company revealed that the FDA had identified deficiencies in the current good manufacturing practice (cGMP) compliance at one of its third-party manufacturing vendors. This information led to a drastic drop in Unicycive's stock price, plummeting by nearly 41% in one day. Following that, on June 30, Unicycive announced that the FDA had issued a Complete Response Letter (CRL) regarding the OLC NDA, further contributing to a sharp decline in share value.

In essence, the accumulative evidence from the lawsuit suggests that the defendants intentionally misled investors regarding the viability and compliance status of their new drug application, significantly impacting stock performance and investor trust.

Company Overview

Unicycive Therapeutics is a biotechnology company specializing in developing and commercializing novel therapies to fulfill unmet medical needs. Its pipeline aims to bring products to market that address significant health issues in the U.S., particularly chronic kidney disease. The legal challenges underscored by this class action could have substantial repercussions on its operational integrity and market credibility.

Founded over 85 years ago, Pomerantz LLP has earned a reputation for championing investors' rights in cases of corporate misconduct and securities fraud. Over the years, the firm has secured billions in damages for its clients, solidifying its status within the legal landscape of class action lawsuits.

Those affected by the allegations against Unicycive and wishing to explore their legal options can find further details through Pomerantz's dedicated contact channels, where legal professionals stand ready to assist potential claimants in joining this significant class action lawsuit.