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

Class Action Lawsuit Against Unicycive Therapeutics

On August 27, 2025, Pomerantz LLP announced the filing of a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and several of its officers, highlighting significant concerns regarding investor protection and the transparency of financial disclosures. The class action has been lodged in the United States District Court for the Northern District of California, with a case number of 25-cv-06923.

Background of the Case

This legal challenge is aimed at all individuals and entities, other than the named defendants, who purchased or acquired Unicycive securities during the period from March 29, 2024, to June 27, 2025, known as the Class Period. Investors are seeking to recover damages resulting from the defendants' alleged violations of federal securities laws, specifically references to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as well as Rule 10b-5.

In the realm of biotechnology, Unicycive focuses on developing therapies to meet critical medical needs, including the innovative oxylanthanum carbonate (OLC), which targets hyperphosphatemia in chronic kidney disease (CKD) patients requiring dialysis. Throughout the Class Period, several representations made by the company's officials regarding the promising regulatory trajectory and compliance with the U.S. Food and Drug Administration (FDA) standards have been called into question by the allegations made in this lawsuit.

Allegations Against Unicycive

The lawsuit alleges that Unicycive executives consistently overstated the company's readiness to meet FDA compliance requirements. This included misleading statements concerning the progress of the New Drug Application (NDA) for OLC that were deemed to misinform investors about the company's operational integrity and regulatory compliance. In September 2024, it was announced that the NDA for OLC was submitted to the FDA, raising expectations among stakeholders.

However, this optimism was short-lived. On June 10, 2025, Unicycive revealed that the FDA had identified significant deficiencies in cGMP (current good manufacturing practices) compliance at a third-party manufacturer utilized by the company, following an inspection of the facility. This disclosure led to a 40.89% drop in Unicycive’s stock price, reflecting a sharp reaction from investors responding to news of potential regulatory setbacks.

Further complicating matters, on June 30, 2025, Unicycive announced a Complete Response Letter (CRL) received from the FDA, denoting that no approval would be granted until the revealed deficiencies were adequately resolved. As a result, the stock plunged an additional 29.85%, emphasizing the critical nature of the upcoming resolution and investor confidence.

Seeking Justice for Investors

Investors who acquired Unicycive securities during the Class Period have until October 14, 2025, to file a motion to appoint themselves as Lead Plaintiff in the class action. Pomerantz LLP strongly encourages those affected to reach out for more information regarding their potential claims and to obtain a copy of the official complaint.

Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust litigation, having recovered billions for clients in similar lawsuits over its 85-year history. The firm’s establishment was pioneered by Abraham L. Pomerantz, a renowned figure in the field of class action law, reinforcing its mission to advocate for the rights of those harmed by securities fraud and corporate misconduct.

For further inquiries or to discuss your legal options regarding this class action, you may contact attorney Danielle Peyton at Pomerantz LLP via email or phone. Detailed information is also available on their website.

This case underscores the importance of corporate accountability and transparency, particularly within the biotechnology industry, where investor trust is heavily reliant on the accurate representation of product development and regulatory paths. As this lawsuit progresses, all eyes will be on Unicycive Therapeutics and the outcomes of these serious allegations.