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

Pomerantz Law Firm's Class Action Against Unicycive Therapeutics

On October 8, 2025, Pomerantz LLP announced a significant step in investor rights by filing a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and certain of its executives. The legal proceedings, lodged in the United States District Court for the Northern District of California, focus on claims that the company and its leaders made materially misleading statements about its financial health and regulatory readiness.

The class action encompasses all individuals and entities, excluding the defendants, who acquired Unicycive securities between March 29, 2024, and June 27, 2025. This timeframe marks critical developments for the company, particularly surrounding its efforts to gain approval from the U.S. Food and Drug Administration (FDA) for its novel product, oxylanthanum carbonate (OLC), intended for use in treating hyperphosphatemia among chronic kidney disease (CKD) patients on dialysis.

Pomerantz LLP's focus in this case is to recover damages for affected investors, asserting that the defendants violated federal securities laws, particularly sections of the Securities Exchange Act of 1934 and Rule 10b-5. Between the dates mentioned, Unicycive publicly assured stakeholders of its compliance with FDA manufacturing standards and the readiness of its New Drug Application (NDA) for OLC.

In the lead-up to the lawsuit, Unicycive had announced in September 2024 that it had submitted its NDA to the FDA, raising investor expectations. However, according to the plaintiffs’ complaint, the company and its executives repeatedly overstated its readiness to meet the FDA's requirements. This assertion came before several disheartening updates regarding the submission process.

Specifically, on June 10, 2025, Unicycive disclosed that the FDA identified significant deficiencies in the manufacturing practices of a third-party vendor, following a routine inspection. The revelation caused Unicycive's stock to plummet by nearly 41%, representing a loss of $3.68 per share, closing at $5.32. This steep decline highlighted the immediate impact of the alleged misleading statements. Subsequently, on June 30, 2025, further news arrived that the FDA issued a Complete Response Letter (CRL) concerning the NDA due to ongoing compliance issues, with the stock falling an additional 29.85%, closing at $4.77 per share.

Pomerantz LLP has experience dealing with securities litigation, having fought passionately for investor justice for over 85 years. The firm has a history of recovering billions of dollars in damages for those impacted by financial misconduct. The announcement of this class action serves not only to pursue compensation for affected investors but also to uphold corporate accountability in the biotech sector.

For those who purchased Unicycive securities during the specified class period, it is crucial to note the deadline of October 14, 2025, to request lead plaintiff status in this case. Interested investors can find more details on the complaint at www.pomerantzlaw.com.

Inquiries regarding the case can be directed to Danielle Peyton at Pomerantz LLP via phone at 646-581-9980 or through email.

This case is a stark reminder of the importance of transparent communication in the corporate world, particularly when the stakes involve the health and safety of patient populations reliant on innovative therapies. As the legal proceedings unfold, stakeholders await clarity on accountability and corporate governance moving forward.