#United States #San Francisco #Pomerantz LLP #Unicycive #OLC

Class Action Lawsuit Filed Against Unicycive Therapeutics

Pomerantz LLP has declared the initiation of a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY), focusing on the activities of specific company officers. This legal action was filed in the United States District Court for the Northern District of California under docket number 25-cv-06923. The case seeks to represent all individuals and entities other than the defendants who purchased Unicycive's securities during the designated class period, which spans from March 29, 2024, to June 27, 2025. The lawsuit aims to recover losses attributed to misrepresentations and omissions that violate federal securities laws, particularly under the Securities Exchange Act of 1934.

The complaint indicates the firm is probing Unicycive for overstatements made regarding the progress of its New Drug Application (NDA) for a therapy known as oxylanthanum carbonate (OLC). OLC is designed to treat hyperphosphatemia - a common issue for chronic kidney disease patients undergoing dialysis. Throughout the class period, Unicycive consistently communicated confidence regarding its NDA being in alignment with the U.S. Food and Drug Administration's (FDA) manufacturing compliance standards.

In September 2024, the company reported that it had submitted the NDA for OLC to the FDA, fueling investor optimism. However, the subsequent class action points out that the company allegedly failed to disclose significant issues concerning its compliance with FDA's manufacturing requirements. It is claimed that statements made by Unicycive officials suggested an exaggerated readiness regarding these regulatory standards.

On June 10, 2025, Unicycive experienced a dramatic downturn after announcing deficiencies in good manufacturing practices (GMP) at a third-party contractor, revealed through an FDA inspection. This led to Unicycive's stock price dropping significantly by nearly 41%, as investors reacted to the news of potential regulatory setbacks for the OLC NDA. Just a few weeks later, on June 30, the firm confirmed that the FDA had issued a Complete Response Letter (CRL) for the NDA, confirming prior deficiencies. The fallout resulted in another steep drop in Unicycive's stock, marking a clear volatility in response to the company's regulatory troubles.

This lawsuit by Pomerantz highlights a dedication to holding companies accountable for misstatements and misleading communications that can adversely affect investors. The firm has a robust history in championing the rights of investors facing fraudulent activities within the securities landscape. Individuals impacted by the alleged misconduct have until October 14, 2025, to petition the court to appoint them as Lead Plaintiff, which allows for direct representation in the case against Unicycive.

As the case unfolds, it will undoubtedly draw the attention of shareholders and financial analysts alike who are keen on understanding the implications of corporate governance and compliance, especially within a sector as crucial as biotechnology that directly influences patient well-being and research advancements.

If you purchased or acquired Unicycive securities during the specified period, you are encouraged to review the complaint available at Pomerantz Law Firm's website or reach out to Danielle Peyton at 646-581-9980 for further details. The essence of this lawsuit is not only protective of individual investors but indicative of broader compliance challenges within emerging biopharmaceutical firms.

Pomerantz Law Firm, with its offices spread across major cities such as New York, Chicago, and London, remains committed to seeking justice and reparations for those wronged by corporate malpractice in the financial sector. With an impressive legacy that dates back to its founder Abraham L. Pomerantz, the firm continues to be a pillar in the arena of securities class actions, shaping the legal landscape for investor rights in America.