Pomerantz Law Firm Initiates Class Action Against Unicycive Therapeutics for Securities Violations

Class Action Lawsuit Against Unicycive Therapeutics: What You Need to Know

In a significant legal action, Pomerantz LLP has announced the filing of a class action lawsuit against Unicycive Therapeutics, Inc., alongside certain officers of the company. The suit has been officially recorded in the U.S. District Court for the Northern District of California under docket number 25-cv-06923. This legal move comes as a response to claims of securities violations made by the defendants during a specific class period from March 29, 2024, to June 27, 2025.

The lawsuit primarily targets individuals and entities who purchased or acquired Unicycive securities during this designated timeframe. The plaintiffs seek to recover damages attributed to alleged infractions of federal securities laws, specifically under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5. Those affected by these developments have a deadline of October 14, 2025, to petition the court for their appointment as Lead Plaintiff in this class action.

Unicycive Therapeutics is a biotechnology firm in the clinical stage, focusing on the identification and commercialization of therapies aimed at addressing unmet medical needs within the United States. One of their notable pipeline products is oxylanthanum carbonate (OLC), which they have promoted as a next-generation treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis.

Throughout the class period, Unicycive management has been vocal about their confidence regarding a New Drug Application (NDA) for OLC. Defendants have reportedly assured investors about the company's capability to meet the manufacturing compliance standards set forth by the U.S. Food and Drug Administration (FDA).

However, the complaint asserts that these claims were significantly exaggerated. Allegations have surfaced indicating that the company’s readiness to comply with the FDA’s manufacturing requirements was overstated and that the regulatory outlook for the OLC NDA was similarly inflated. As the lawsuit indicates, these misrepresentations are deemed materially false and misleading at all pertinent times.

In September 2024, Unicycive publicly disclosed the submission of the OLC NDA to the FDA, which initially seemed to affirm their confidence in the product's development. However, subsequent announcements have raised serious concerns. On June 10, 2025, Unicycive reported findings from an FDA inspection identifying deficiencies in current good manufacturing practice (cGMP) compliance at one of its third-party manufacturers. Consequently, they stated that potential discussions regarding product labeling with the FDA were no longer feasible, which led to a drastic drop in share price by nearly 41% in a single day.

This announcement was followed by another press release on June 30, 2025, where the company revealed that the FDA had issued a Complete Response Letter (CRL) for the OLC NDA, citing the pre-existing cGMP deficiencies. Predictably, Unicycive's stock took another significant hit, dropping nearly 30% in value.

Pomerantz LLP, recognized as a leader in corporate, securities, and antitrust class litigation, emphasizes its commitment to fighting for the rights of investors and stakeholders subjected to corporate misconduct. Founded over 85 years ago by Abraham L. Pomerantz, the firm has amassed billions in damages recovered on behalf of the class members to date.

This lawsuit serves as a critical juncture for investors and stakeholders involved with Unicycive. If you believe you have been affected by these developments, it's imperative to secure legal representation and potentially join the class action to seek rightful reparations. For further details regarding this case or to access a copy of the Complaint, interested parties can consult Pomerantz Law.

For any inquiries, Danielle Peyton from Pomerantz LLP can be contacted at [email protected] or via phone at 646-581-9980.

As these legal proceedings unfold, the implications for Unicycive Therapeutics and its stakeholders could be substantial, emphasizing the importance of transparency and accountability in the biotechnology sector.