SAN DIEGO, Sept. 8, 2026 /PRNewswire/ -- Shareholder rights law firm Robbins LLP reminds investors that a class action was filed on behalf of persons and entities who purchased or otherwise acquired Unicycive Therapeutics, Inc. (NASDAQ: UNCY) securities between December 29, 2025 and June 29, 2026. Unicycive is a clinical-stage biotechnology company that identifies, develops, and commercializes therapies for the treatment of kidney diseases.
The complaint alleges that Unicycive failed to properly inspect its third-party vendor's manufacturing facility to ensure it resolved the U.S. Food and Drug Administration's ("FDA") previously noted deficiencies.
Investors who suffered significant losses during the Class Period may be eligible to participate in the lawsuit and should contact Robbins LLP before the November 2, 2026, lead plaintiff deadline.
Why Was Unicycive Sued?
According to the complaint, Unicycive submitted a New Drug Application ("NDA") for its kidney disease therapy, oxylanthanum carbonate ("OLC"), to the FDA in September 2024. The NDA was accepted by the FDA in November 2024. In June 2025, the FDA issued a Complete Response Letter ("CRL") citing deficiencies at a third-party manufacturing vendor. Following the CRL, Unicycive held a Type A meeting with the FDA in October 2025 to discuss the single deficiency related to the third-party manufacturing vendor's compliance status. After receiving official meeting minutes and engaging with the vendor, Unicycive resubmitted the NDA in December 2025.
Plaintiff alleges that, during the class period, defendants failed to disclose to investors:
(1) that the Company had not inspected its third-party manufacturing vendor's facility or otherwise audited the facility's compliance with current good manufacturing practices;
(2) that, as a result, the Company lacked a reasonable basis to believe that the vendor had resolved the FDA's cited deficiencies;
(3) that there was an undisclosed risk that the FDA would require additional information about the vendor's facility's manufacturing practices;
(4) that, as a result, the regulatory approval of OLC was reasonably likely to be delayed; and
(5) that, 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.
Why Did UNCY Stock Drop?
On June 30, 2026, before the market opened, Unicycive disclosed that the FDA had issued a CRL regarding the Company's resubmitted NDA for OLC, identifying the "same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025."
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.
Who May Be Eligible to Participate in the Unicycive Class Action?
The lawsuit seeks to represent investors who purchased or otherwise acquired Unicycive Therapeutics, Inc. securities between December 29, 2025 and June 29, 2026. Investors who suffered losses during that period may have legal rights under the federal securities laws.
What Is a Lead Plaintiff?
The lead plaintiff is a court-appointed investor who represents the interests of all class members throughout the litigation. Serving as lead plaintiff is not required to share in any potential recovery. Investors who do not seek appointment may remain absent class members if the case proceeds and later resolves successfully.
Stockholders who wish to lead the class action should contact Robbins LLP before the November 2, 2026, lead plaintiff deadline.
Does it cost anything to participate?
No. Robbins LLP represents investors on a contingency fee basis.
Contact Robbins LLP
Investors seeking additional information about the Unicycive Therapeutics, Inc. securities class action may contact Robbins LLP by submitting an inquiry, emailing attorney Aaron Dumas, Jr., or calling (800) 350-6003.
About Robbins LLP
A recognized leader in shareholder rights litigation, Robbins LLP represents investors in securities fraud and shareholder derivative litigation. We have helped restore more than $1 billion in value to shareholders and secured some of the largest recoveries in shareholder derivative litigation history.
"Companies have an obligation to provide investors with complete and accurate information so that markets can function fairly and efficiently," said Brian J. Robbins, Founding Partner of Robbins LLP.
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SOURCE Robbins LLP
