Overview

A class action lawsuit has been filed against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) and certain of the Company’s current senior executive officers alleging violations of the federal securities laws. The Company’s common stock trades in an efficient market on the Nasdaq Capital Market (“NASDAQ”) under the ticker symbol “UNCY.”

The Unicycive class action lawsuit was brought on behalf of all persons and entities who purchased or otherwise acquired Unicycive securities between March 29, 2024, and June 27, 2025, both dates inclusive, (the “Class Period”).

Unicycive is a clinical-stage biotechnology company that identifies, develops, and commercializes therapies to address unmet medical needs in the U.S. The Company is developing, among other therapies, oxylanthanum carbonate (“OLC”), a purported next-generation phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease (“CKD”) patients on dialysis.

The Unicycive lawsuit alleges that the Company consistently misrepresented the regulatory prospects of its New Drug Application for OLC, a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. At all relevant times, the Company and its executives touted their readiness to satisfy the Food and Drug Administration’s manufacturing compliance requirements, repeatedly assuring investors and analysts of the strength of its operations and the likelihood of approval. In September 2024, Unicycive formally announced the submission of the OLC NDA to the FDA, further bolstering market confidence in the Company’s strategy.

Throughout the class period, however, the Company is alleged to have made materially false and misleading statements concerning its compliance and regulatory readiness. According to the lawsuit, Unicycive overstated its ability to meet the FDA’s manufacturing requirements, exaggerated the likelihood of approval, and failed to disclose critical deficiencies. As a result, investors were allegedly misled about the true risks associated with the NDA and the Company’s operations.

On June 10, 2025, the alleged truth began to emerge when Unicycive issued a press release disclosing that the FDA had identified significant deficiencies in current good manufacturing practice compliance at a third-party subcontractor of the Company’s contract development and manufacturing organization. The Company admitted that because of these deficiencies, any label discussions with the FDA were precluded. Following this disclosure, Unicycive’s stock price dropped by $3.68 per share, or 40.89%, closing at $5.32.

Further damaging news followed on June 30, 2025, when Unicycive announced that the FDA had issued a Complete Response Letter for the OLC NDA. This development drove the Company’s stock down another $2.03 per share, or 29.85%, to close at $4.77.

As a result of these alleged wrongful acts and omissions, and the sharp decline in the Company’s stock price, class members are said to have sustained significant losses and damages tied directly to the decline in market value of Unicycive’s securities.

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If you purchased or otherwise acquired Unicycive securities between March 29, 2024, and June 27, 2025, both dates inclusive, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as lead plaintiff in the Unicycive class action lawsuit is October 14, 2025.