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Unicycive Therapeutics, Inc.

Securities Class Action

  • Date:
  • 8/22/2025
  • Company Name:
  • Unicycive Therapeutics, Inc.
  • Stock Symbol:
  • UNCY
  • Status:
  • Investigating

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What’s Happening:
  •  Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ:UNCY) in the United States District Court for the Northern District of California 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”).
  • Investors have until October 14, 2025  to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Allegation Details:
 
  • According to the complaint, defendants touted the prospects of its New Drug Application ("NDA") for oxylanthanum carbonate ("OLC") for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis and assured investors of the Company's readiness and ability to satisfy the U.S. Drug and Food Administration's ("FDA") manufacturing compliance requirements. The complaint further alleges, however, that defendants failed to disclose that Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated.
 
  • On June 10, 2025, Unicycive announced 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, the price of Unicycive's stock fell over 40%. Then, on June 30, 2025, Unicycive announced that the FDA had issued a Complete Response Letter for the OCL NDA, citing the previously identified cGMP deficiencies at the third-party subcontractor of its CDMO. On this news, Unicycive's stock fell almost 30%, to close at $4.77 per share on June 30, 2025.
 
Next Steps:
 
  • If you purchased or otherwise acquired Unicycive shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out the form below.  There is no cost or obligation to you.
Contact Instructions
Please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com with any questions regarding the case.
The individual or institution below (“Plaintiff”) has reviewed and agrees to the Bragar Eagel & Squire, P.C. (“BESPC”) retainer agreement and authorizes BESPC to prosecute an action on Plaintiff’s behalf under the federal securities laws or applicable state laws to recover damages on behalf of investors in Unicycive Therapeutics. BESPC will prosecute the action on a full contingency basis and will forward all costs and expenses.
 

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