Unicycive Therapeutics, Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., one of the nation's premier class action law firms specializing in securities fraud cases, is investigating potential claims against Unicycive Therapeutics, Inc. (UNCY)

If you purchased or acquired Unicycive Therapeutics, Inc. securities between March 29, 2024 and June 27, 2025, you may be eligible to join this class action lawsuit and seek compensation for your losses.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company founded in 2016 and headquartered in Los Altos, California. The company focuses on inventing and developing medications designed to improve the quality of life for patients with kidney disease.

Its primary product under development is oxylanthanum carbonate (OLC), a next-generation phosphate binder intended for patients with chronic kidney disease (CKD) on dialysis. Its business model relies heavily on the successful development and regulatory approval of its lead drug candidates.

The Allegations

The class action lawsuit alleges that Unicycive Therapeutics and certain executives made materially false and misleading statements, or failed to disclose key information, regarding the company’s ability to meet the U.S. Food and Drug Administration’s (FDA) manufacturing compliance requirements for its OLC drug candidate.

The complaint claims that Unicycive overstated its readiness to satisfy FDA requirements and the regulatory prospects for its OLC New Drug Application (NDA). Throughout the class period (from March 29, 2024 to June 27, 2025) Unicycive and its management regularly assured investors of their progress and readiness for FDA approval.

However, on June 10, 2025, the company revealed that the FDA had "identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO's third-party subcontractors and not its Drug Substance vendor) following an FDA inspection." This news abruptly halted any label discussions with the FDA and cast serious doubt on the likelihood of approval.

Following this disclosure, Unicycive’s stock price plummeted by nearly 40% in a single day, erasing tens of millions of dollars in market value.

On June 30, 2025, the company issued a press release announcing that the FDA has issued a Complete Response Letter (“CRL”) for the OLC NDA. On this news, the stock fell another 26%.

These drops appears to be a direct response to the FDA announcement and CRL, as broader market indices were actually rising on these days. The complaint further alleges that prior public statements by Unicycive failed to disclose the existence or risk of these manufacturing issues, allegedly misleading investors about the true state of the company’s regulatory progress.

Important Dates

• Class period: March 29, 2024 to June 27, 2025
• Lead plaintiff deadline: October 14, 2025
• Complaint filed: August 15, 2025

Your Rights and Next Steps

If you purchased or otherwise acquired Unicycive Therapeutics securities during the class period, you may have the right to participate in this class action lawsuit. Investors who suffered financial losses due to the alleged misrepresentations can seek to recover their damages through the court process.

You do not need to take any action to remain a potential class member at this stage. However, if you wish to serve as the lead plaintiff (the representative party who acts on behalf of all other class members) you must file a motion with the court no later than October 14, 2025. The lead plaintiff plays an important role in directing the litigation and negotiating any potential settlement.

Lawyers are ready to help you understand your rights and guide you through the process. There are no out-of-pocket costs to participate, and you may be entitled to a share of any recovery if the lawsuit is successful.

You May Be Entitled to Compensation

If you invested in Unicycive Therapeutics between March 29, 2024 and June 27, 2025 and experienced losses after the company’s stock price fell, you may be eligible to join the lawsuit and seek compensation.

To find out if you qualify and to take the next step, complete the form below. Lawyers are ready to help you evaluate your claim and answer your questions.