Pomerantz Law Firm Files Class Action Against Unicycive Therapeutics Over Securities Violations

Pomerantz Law Firm Files Class Action Against Unicycive Therapeutics

In a significant legal move, Pomerantz LLP has announced the filing of a class action lawsuit against Unicycive Therapeutics, Inc., a clinical-stage biotechnology company known for developing therapies that aim to meet critical medical needs. This lawsuit, which has been registered with the United States District Court for the Northern District of California, specifically targets the company and its executives for perceived violations of federal securities laws during a defined class period spanning from March 29, 2024, to June 27, 2025.

Context and Implications of the Lawsuit

Investors who acquired Unicycive securities during this timeframe may be impacted by the alleged misconduct that the lawsuit seeks to address. The suit highlights significant discrepancies between the company’s public disclosures and the true state of its product development and compliance readiness regarding regulatory standards. As per the complaint, Unicycive's representations about its New Drug Application (NDA) for oxylanthanum carbonate (OLC), a drug intended to treat hyperphosphatemia in chronic kidney disease (CKD) patients, were misleading.

The allegations center around assertions made by Unicycive's leadership regarding the company's ability to meet the U.S. Food and Drug Administration's (FDA) manufacturing compliance requirements. Throughout the class period, the company had consistently communicated a robust image of its readiness to secure FDA approval for OLC, claiming that it had successfully submitted its NDA in September 2024. However, the complaint contends that Unicycive overstated its readiness and ability to comply with regulatory mandates, leading to materially false and misleading statements that misled investors.

Key Events and Decline in Share Value

The situation escalated dramatically on June 10, 2025, when Unicycive issued a press release recognizing deficiencies in its manufacturing compliance identified by the FDA during an inspection of a third-party vendor. This revelation triggered a substantial decline in Unicycive's stock price, falling $3.68 per share, or approximately 40.89%, to close at $5.32. Shortly thereafter, on June 30, the company announced that the FDA had delivered a Complete Response Letter (CRL) concerning the NDA for OLC. This letter reiterated the issues with manufacturing compliance, resulting in an additional drop in stock price by $2.03, or nearly 29.85%, closing at $4.77 per share.

Next Steps for Investors

Investors who acquired Unicycive securities during the defined class period have until October 14, 2025, to act on their rights, including the opportunity to petition the Court to appoint them as Lead Plaintiff in the ongoing class action. Detailed information regarding participation can be obtained through the Pomerantz website, alongside access to the full complaint.

Company Background

Unicycive Therapeutics specializes in the development of therapeutics aimed at alleviating significant unmet medical needs. In addition to oxylanthanum carbonate, the company has a pipeline focused on various potential treatment modalities. However, the recent developments have raised pressing concerns around the viability of its product offerings and the accuracy of management's past assurances.

Pomerantz LLP, recognized as a pioneering firm in class action-related litigation, particularly in the realms of corporate and securities claims, emphasizes its commitment to advocating for the rights of investors facing corporate misconduct. Founded by the esteemed Abraham L. Pomerantz, the firm has a long-standing history of securing favorable outcomes for its clients amid complex legal challenges in the corporate sphere.

For affected investors seeking clarity on the situation or wishing to join the class action, they are encouraged to reach out to the firm’s contact, Danielle Peyton, for further discourse and next steps.

In the wake of this lawsuit, the unfolding narrative around Unicycive Therapeutics emphasizes the broader implications for transparency and accountability within the biotech sector, reflecting pervasive challenges that investors may face in navigating the complex landscape of biopharmaceutical investments.