1. A class action was filed against Unicycive for misleading investors. 2. Allegations involve overstatements regarding FDA manufacturing compliance readiness. 3. Unicycive's stock dropped over 70% following FDA compliance issues. 4. Investors can participate in the class action before October 14, 2025. 5. Unicycive has failed to meet FDA compliance, impacting its drug approval.
The substantial drop in stock price post-FDA announcements indicates profound investor distrust. Historical precedent shows class actions can lead to further losses and prolonged recovery times for affected companies.
The class action and FDA compliance failures directly impact investor confidence and stock valuation, making the article highly relevant to UNCY's performance.
The immediate repercussions of the class action and FDA compliance issues will likely affect UNCY's stock in the short term, as investor sentiment can shift quickly in response to legal actions.
SAN DIEGO, Aug. 18, 2025 /PRNewswire/ -- Robbins LLP informs stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Unicycive Therapeutics, Inc. (NASDAQ:UNCY) securities between March 29, 2024 and June 27, 2025. Unicycive is a clinical-stage biotechnology company that identifies, develops, and commercializes therapies to address unmet medical needs in the U.S.
For more information, submit a form, email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
The Allegations: Robbins LLP is Investigating Allegations that Unicycive Therapeutics, Inc. (UNCY) Misled Investors Regarding the Readiness of its Drug Prospect
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.
What Now: You may be eligible to participate in the class action against Unicycive Therapeutics, Inc. Shareholders who want to serve as lead plaintiff for the class should contact Robbins LLP before the October 14, 2025, deadline to move for lead plaintiff. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002.
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SOURCE Robbins LLP