NEW YORK, Aug. 18, 2025 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all persons or entities who purchased or otherwise acquired Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) securities between March 29, 2024 and June 27, 2025, inclusive (the “Class Period”).
The Complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company’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, the Company issued a press release “announc[ing] an update on its New Drug Application [NDA] for oxylanthanum carbonate [OLC] to treat hyperphosphatemia in patients with chronic kidney disease [CKD] on dialysis.” 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 the Company’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, the Company’s stock price dropped $3.68 per share, or 40.89%, to close at $5.32 per share on June 10, 2025.
Investors who purchased or otherwise acquired shares of Unicycive should contact the Firm prior to the October 14, 2025 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected].
Please visit our website at http://www.gme-law.com for more information about the firm.
