Unicycive Therapeutics, Inc. (NASDAQ: UNCY) Securities Fraud Class Action

The Unicycive Therapeutics, Inc. securities fraud class action lawsuit was filed on behalf of those who purchased or otherwise acquired Unicycive Therapeutics, Inc. (“Unicycive”) (NASDAQ: UNCY) securities between December 29, 2025 and June 29, 2026, inclusive (the “Class Period”). Captioned Patel v. Unicycive Therapeutics, Inc., No. 26-cv-09559 (N.D. Cal.), the Unicycive class action lawsuit alleges that Unicycive and/or certain of its officers and/or directors violated federal securities laws by making false or misleading statements and/or omitted to disclose material information.

If you lost money as a result of your Unicycive investment and want to find out more about this action and your rights, fill out the form on this page or contact attorney Jonathan Naji, Esq. of KTMC by calling (484) 270-1453 or via e-mail at [email protected]. 

COMPLAINT ALLEGATION SUMMARY:
Unicycive is a clinical-stage biotechnology company, identifies, develops, and commercializes therapies for the treatment of kidney diseases.

In September 2024, Unicycive submitted a New Drug Application (“NDA”) for its kidney disease therapy, oxylanthanum carbonate (“OLC”), to the U.S. Food and Drug Administration (“FDA”). The NDA was accepted by the FDA in November 2024. In June 2025, the FDA issued a Complete Response Letter (“CRL”) citing deficiencies at a third-party manufacturing vendor. Following the CRL, Unicycive held a Type A meeting with the FDA in October 2025 to discuss the single deficiency related to the third-party manufacturing vendor’s compliance status. In December 2025, after receiving official meeting minutes and engaging with the vendor, Unicycive resubmitted the OLC NDA.

The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material facts about the company’s business, operations, and prospects. Specifically, Defendants misrepresented and/or failed to disclose that: (1) the company had not inspected its third-party manufacturing vendor’s facility or otherwise audited the facility’s compliance with current good manufacturing practices; (2) the company lacked a reasonable basis to believe that the vendor had resolved the FDA’s cited deficiencies; (3) there was an undisclosed risk that the FDA would require additional information about the vendor facility’s manufacturing practices; (4) given these failures, the regulatory approval of OLC was reasonably likely to be delayed; and (5) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

WHY DID UNICYCIVE’S STOCK DROP?
On June 30, 2026, before the market opened, Unicycive disclosed that the FDA issued a CRL regarding the company’s resubmitted NDA for OLC, identifying the “same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025.” On this news, the price of Unicycive common stock declined more than 39%, from a close of $7.70 per share on June 29, 2026, to close at $4.69 per share on June 30, 2026.

THE LEAD PLAINTIFF PROCESS:
The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Unicycive securities during the Class Period to seek appointment as lead plaintiff in the Unicycive class action lawsuit. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including being recognized in Chambers & Partners USA 2026 as a Band 1 Top Firm in Securities and Class Actions, Legal 500’s Tier 1 Rankings for Securities and M&A Litigation, The National Law Journal’s Plaintiff’s Hot List and Trailblazers in Plaintiffs’ Law, BTI Consulting Group’s Honor Roll of Most Feared Law Firms, The Legal Intelligencer’s Class Action Firm of the Year, Lawdragon’s Leading Plaintiff Financial Lawyers, and Law360’s Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. KTMC has recovered over $25 billion for our clients and the classes they represent.