Pomerantz Law Firm Announces the Filing of a Class Action Against Unicycive Therapeutics, Inc. and Certain Officers - UNCY

NEW YORK, Sept. 3, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) and certain officers.  The class action, filed in the United States District Court Northern District of California, and docketed under 25-cv-06923, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Unicycive securities between March 29, 2024 and June 27, 2025, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are an investor who purchased or otherwise acquired Unicycive securities during the Class Period, you have until October 14, 2025, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.  

[Click here for information about joining the class action]

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. 

At all relevant times, Defendants consistently touted the prospects of a New Drug Application ("NDA") for OLC for the treatment of hyperphosphatemia in CKD patients on dialysis (the "OLC NDA"), assuring investors and analysts of the Company's readiness and ability to satisfy the U.S. Food and Drug Administration's ("FDA"), inter alia,  manufacturing compliance requirements.

In September 2024, Unicycive announced that it had submitted the OLC NDA to the FDA.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the OLC NDA's regulatory prospects were likewise overstated; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times.

On June 10, 2025, Unicycive issued a press release "announc[ing] an update on its [NDA] for [OLC] to treat hyperphosphatemia in patients with [CKD] on dialysis."  Therein, the Company disclosed that the FDA "had identified deficiencies in cGMP [current good manufacturing practice] compliance at a third-party manufacturing vendor"—specifically, a third-party subcontractor of Unicycive's contract development and manufacturing organization ("CDMO")—"following an FDA inspection" and that, "given the identified deficiencies, any label discussions between the FDA and the Company are precluded."

On this news, Unicycive's stock price fell $3.68 per share, or 40.89%, to close at $5.32 per share on June 10, 2025.

Then, on June 30, 2025, Unicycive issued a press release announcing that the FDA had issued a Complete Response Letter ("CRL") for the OLC NDA, citing the previously identified cGMP deficiencies at the third-party subcontractor of its CDMO.

On this news, Unicycive's stock price fell $2.03 per share, or 29.85%, to close at $4.77 per share on June 30, 2025.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com. 

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CONTACT:
Danielle Peyton
Pomerantz LLP
[email protected]
646-581-9980 ext. 7980

SOURCE Pomerantz LLP