A securities class action has been filed against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) and certain executive officers on behalf of persons and entities that purchased or otherwise acquired Unicycive securities between December 29, 2025 and June 29, 2026, inclusive (the “Class Period”).
The action, Patel v. Unicycive Therapeutics, Inc., et al., Case No. 3:26-cv-09559, was filed on September 3, 2026 in the U.S. District Court for the Northern District of California and alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.
If you acquired Unicycive securities during the Class Period and suffered a financial loss, contact Kehoe Law Firm to discuss your legal rights without cost or obligation.
What Does the Unicycive Therapeutics Securities Class Action Allege?
The complaint alleges that, throughout the Class Period, defendants made materially false and/or misleading statements and failed to disclose material adverse facts about the Company’s business, operations, and prospects.
Specifically, the complaint alleges that defendants failed to disclose to investors:
- The Company had not inspected its third-party manufacturing vendor’s facility or otherwise audited the facility’s compliance with current good manufacturing practices;
- As a result, the Company lacked a reasonable basis to believe that the vendor had resolved the FDA’s cited deficiencies;
- There was an undisclosed risk that the FDA would require additional information about the vendor’s facility’s manufacturing practices;
- As a result of the foregoing, the regulatory approval of oxylanthanum carbonate (“OLC”) was reasonably likely to be delayed; and
- As a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
The June 30, 2026 Disclosure and UNCY Stock Decline
According to the complaint, on June 30, 2026, before the market opened, Unicycive disclosed that the U.S. Food and Drug Administration (“FDA”) had issued a second Complete Response Letter (“CRL”) regarding the Company’s resubmitted New Drug Application (“NDA”) for OLC, identifying the “same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025.”
The complaint states that Unicycive disclosed that the FDA had not yet conducted its inspection of the third-party manufacturing vendor as part of the review of the resubmitted NDA. The Company also stated that the OLC NDA had been resubmitted based on Unicycive’s belief that the original third-party manufacturing vendor was making continued progress in resolving FDA-cited deficiencies and demonstrating inspection readiness. The FDA did not raise concerns regarding OLC’s clinical efficacy or safety data, and no additional data was requested.
The complaint alleges that, on this news, Unicycive’s stock price fell $3.01, or 39.1%, to close at $4.69 per share on June 30, 2026, on unusually heavy trading volume.
Unicycive Therapeutics Investors: Contact Kehoe Law Firm
Investors who purchased or otherwise acquired Unicycive securities during the Class Period and suffered financial losses are encouraged to complete Kehoe Law Firm’s confidential Stockholder Information Request Form or send us a message to discuss their legal rights.
For a free, no-obligation legal evaluation, contact:
Michael Yarnoff, Esq.
(215) 792-6676, Ext. 804
[email protected]
[email protected]
Lead Plaintiff Deadline: November 2, 2026. Investors who wish to seek appointment as lead plaintiff must do so by November 2, 2026. Investors do not need to seek appointment as lead plaintiff to remain potential members of the proposed class or to be eligible to share in any potential recovery.
About Kehoe Law Firm, P.C.
Kehoe Law Firm, P.C. is a nationally recognized, plaintiff-side class action law firm representing investors, consumers, and employees in matters involving securities fraud, corporate misconduct, mergers and acquisitions, antitrust violations, whistleblower claims, data breaches, consumer fraud, employment law violations, and retirement-plan mismanagement. Its attorneys have served as lead or co-lead counsel in major securities cases, recovering more than $10 billion for institutional and individual investors.
Kehoe Law Firm’s class action legal services are provided on a contingency-fee basis, meaning plaintiffs are not responsible for attorneys’ fees or litigation expenses. Any request for attorneys’ fees and expenses will be subject to court approval.
SEND US A MESSAGE
Contact Us
ADDRESS
Kehoe Law Firm, P.C.
2001 Market Street
Suite 2500
Philadelphia, PA 19103