#USA #California #Class Action #Pomerantz LLP #Unicycive Therapeutics

Pomerantz Law Firm Files Class Action Against Unicycive Therapeutics

In a significant legal development, the Pomerantz Law Firm has officially filed a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and several of its officials. This action, set to unfold in the United States District Court for the Northern District of California, is documented under the reference number 25-cv-06923. The lawsuit aims to represent all individuals and entities, except for the defendants, who purchased or acquired Unicycive securities between March 29, 2024, and June 27, 2025. It seeks to recover damages resulting from alleged violations of federal securities laws committed by the company and its officers.

Context of the Lawsuit

Unicycive Therapeutics is recognized as a clinical-stage biotechnology company committed to developing therapies that fulfill unmet medical needs. One of its primary projects includes the oxylanthanum carbonate (OLC), intended as a next-generation phosphate binder for treating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. However, during the class period, Unicycive allegedly misrepresented its compliance with the manufacturing requirements of the U.S. Food and Drug Administration (FDA) related to the New Drug Application (NDA) for OLC.

Throughout the stated time frame, it is claimed that the officials from Unicycive consistently presented overly optimistic statements concerning the company's readiness to meet regulatory standards, thus misleading investors. Specifically, they are accused of giving false assurances regarding FDA compliance readiness and overstating the regulatory prospects of their NDA submission.

The Deteriorating Situation

In September 2024, Unicycive reported that it had submitted the OLC NDA to the FDA, a milestone that brought renewed attention and interest from investors. However, the optimism soon began to fade. On June 10, 2025, Unicycive disclosed that the FDA had found deficiencies in current Good Manufacturing Practice (cGMP) compliance at a subcontractor responsible for producing OLC. This announcement led to a sharp decline in Unicycive's stock, falling by nearly 41% in one single trading day, illustrating the immediate impact of the news on investor sentiment.

The situation worsened when, on June 30, 2025, the company revealed that the FDA had issued a Complete Response Letter (CRL) regarding the NDA for OLC. This was a direct consequence of previously identified manufacturing issues, further driving the stock plummet and emphasizing the adverse effects of the regulatory roadblocks on Unicycive's market performance.

Legal Implications for Investors

As the lawsuit evolves, investors who acquired Unicycive securities during the class period have until October 14, 2025, to apply to become the Lead Plaintiff for this class action. Those interested in joining the action or obtaining a copy of the Complaint should reach out to the Pomerantz Law Firm. Danielle Peyton, a representative of the firm, can be contacted for more information. Investors are encouraged to provide basic details about their purchases, including mailing addresses and contact information, to facilitate the legal process.

About Pomerantz LLP

Pomerantz LLP, established over 85 years ago and headquartered in major cities including New York, Chicago, and London, is renowned for its work in securities class actions. The firm, which pioneered this area of law under the leadership of Abraham L. Pomerantz, has consistently aimed to protect the rights of investors while holding corporations accountable for misconduct. Pomerantz’s record includes recovering billions for class members in past actions, a testament to its reputation and effectiveness in handling complex legal challenges.