Pomerantz Law Firm Files Class Action Against Unicycive Therapeutics Amid Regulatory Issues

Pomerantz Law Firm Files Class Action Against Unicycive Therapeutics

In a significant development within the pharmaceutical industry, Pomerantz LLP has initiated a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) along with several of its top executives. The lawsuit has been filed in the United States District Court for the Northern District of California, designated as case number 25-cv-06923, and encompasses all individuals and entities who purchased Unicycive securities between March 29, 2024, and June 27, 2025.

The primary aim of the lawsuit is to recover damages that have arisen from alleged violations of federal securities laws committed by the defendants, including misleading claims about the company’s drug development capabilities, particularly concerning their new product, oxylanthanum carbonate (OLC), intended to treat hyperphosphatemia in patients with chronic kidney disease (CKD).

Background of the Lawsuit

Unicycive is a clinical-stage biotechnology company that has focused on developing therapies to meet unmet medical needs. Specifically, OLC is seen as a potentially revolutionary treatment for CKD patients on dialysis. Throughout the outlined class period, Unicycive's leadership consistently assured investors that they were ready to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for OLC. They strongly emphasized that the company met required compliance standards for manufacturing as outlined by the FDA.

However, events took a turn when in September 2024, Unicycive announced it submitted the NDA for OLC. Following this submission, a series of disclosures emerged indicating significant issues relating to the company’s compliance standards, leading to criticisms that the executives had provided misleading information to the public and investors.

Key Allegations

The class action lawsuit emphasizes that the statements made by Unicycive’s executives regarding the company’s operational readiness and the NDA’s prospects were not only misleading but were wholly exaggerated. Key aspects of the allegations include:
1. Overstated Compliance: The lawsuit alleges that Unicycive exaggerated its readiness to meet FDA compliance requirements, leading investors to make investment decisions based on inaccurate information.
2. Misleading NDA Projections: The projections regarding the NDA for OLC were overstated, leaving investors unaware of the potential pitfalls and risks associated with the product’s approval process.
3. Public Miscommunication: The complaints suggest that the defendants failed to adequately disclose critical issues that would impact the success of the NDA, which led to substantial financial losses for investors when the truth surfaced.

On June 10, 2025, Unicycive reported that the FDA had identified compliance deficiencies at a third-party manufacturing vendor, a revelation that triggered a 40.89% drop in the stock price, highlighting the market's immediate reaction to the negative news. Then on June 30, 2025, the company disclosed the issuance of a Complete Response Letter (CRL) from the FDA, further compounding the negative consequences by resulting in a nearly 30% decrease in stock price in a short period.

Call to Action for Investors

Pomerantz LLP is encouraging investors affected by these developments to participate in the class action. Potential lead plaintiffs must file their applications by October 14, 2025. For interested parties, detailed information including a copy of the complaint is available at www.pomerantzlaw.com. Inquiries can also be directed to Danielle Peyton at 646-581-9980 or via email.

This lawsuit not only addresses urgent concerns about corporate transparency and responsibility but also serves as a crucial reminder of the risks investors face in the biotech sector, where regulatory approvals can dramatically impact stock performance and investor confidence. Pomerantz LLP, with its rich history of advocating for investor rights in securities fraud and corporate misconduct, aims to ensure that justice prevails for those affected by the alleged misdeeds of Unicycive Therapeutics.

Who will stand accountable for Unicycive's actions remains to be seen, but the unfolding legal battle will undoubtedly shed light on the practices within biotechnology that must adhere to regulatory guidance, ultimately aiming for the protection of investor interests and the integrity of the broader market.