Unicycive Therapeutics, Inc. Class Action Lawsuit - UNCY

The filed complaint alleges that Unicycive Therapeutics, Inc made materially false and/or misleading statements and/or failed to disclose that: (1) 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) as a result, the Company lacked a reasonable basis to believe that the vendor had resolved the FDA’s cited deficiencies; (3) there was an undisclosed risk that the FDA would require additional information about the vendor’s facility’s manufacturing practices; (4) as a result of the foregoing, 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.

In order to be eligible to join the UNCY class action lawsuit, you must have incurred a loss on shares of Unicycive Therapeutics, Inc. purchased during the class period listed above.

If you suffered a loss in Unicycive Therapeutics, Inc. during the relevant time frame or pursuant to the relevant offering(s), you have until November 2, 2026 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

Key Facts About Unicycive Therapeutics, Inc. (NASDAQ: UNCY)

●       The Allegation: The complaint alleges Unicycive told investors its original third-party manufacturing vendor had made significant progress toward regaining FDA compliance, when the Company had allegedly not inspected or audited the vendor's facility and lacked a reasonable basis to believe the FDA's previously cited deficiencies had been resolved.

●       The Stock Drop: On June 30, 2026, UNCY fell $3.01, or 39.1%, to close at $4.69 per share on unusually heavy trading volume, after the Company disclosed the FDA had issued a second Complete Response Letter citing the same third-party manufacturing deficiencies identified in the June 2025 CRL.

●       Class Period & Defendants: The class period runs from December 29, 2025 through June 29, 2026, inclusive. The named defendants are Unicycive Therapeutics, Inc., Shalabh Gupta (Chief Executive Officer) and John Townsend (Chief Financial Officer).

●       Lead Plaintiff Deadline: November 2, 2026. Investors who wish to seek appointment as lead plaintiff must apply by the deadline.

UNCY Class Action Summary
Company	Unicycive Therapeutics, Inc. (NASDAQ: UNCY)
Lead Plaintiff Deadline	November 2, 2026
Class Period	December 29, 2025 – June 29, 2026
Stock Drop	June 30, 2026 – UNCY fell $3.01 (39.1%) to $4.69

Introduction

A securities class action has been filed against Unicycive Therapeutics, Inc. (NASDAQ: UNCY). The lawsuit was brought by plaintiff Vishal Patel on behalf of investors. It covers the class period from December 29, 2025 through June 29, 2026.

The complaint alleges the Company made materially false and misleading statements about its lead kidney disease drug. Unicycive told investors its manufacturing vendor was making strong progress toward FDA compliance. But the complaint says the Company had not inspected the vendor's facility and lacked a reasonable basis for that claim.

On June 30, 2026, Unicycive disclosed that the FDA had issued a second Complete Response Letter over the same manufacturing problems. UNCY stock fell $3.01, or 39.1%, to close at $4.69 per share that day. Investors who bought during the class period may have suffered significant losses.

Company Profile

Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company that identifies, develops, and commercializes therapies for the treatment of kidney diseases. Its lead product candidate is oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The Company is headquartered in Mountain View, California, and its common stock trades on the NASDAQ under the symbol UNCY.

Class Period

December 29, 2025–June 29, 2026

Investors who purchased or acquired Unicycive Therapeutics (UNCY) securities during the Class Period may be eligible to seek recovery under the federal securities laws.

Allegations

The lawsuit centers on Unicycive's regulatory path for OLC, its investigational treatment for hyperphosphatemia in dialysis patients. The Company submitted a New Drug Application (NDA) for OLC to the FDA in September 2024, and the FDA accepted it in November 2024. In June 2025, the FDA issued a Complete Response Letter citing deficiencies at a third-party manufacturing vendor. After a Type A meeting with the FDA and engagement with the vendor, Unicycive resubmitted the NDA in December 2025. The complaint names Chief Executive Officer Shalabh Gupta and Chief Financial Officer John Townsend as defendants alongside the Company.

According to the complaint, the class period opened on December 29, 2025, when Unicycive announced its NDA resubmission and stated that its original third-party manufacturing vendor had made significant progress toward regaining FDA compliance. In the weeks that followed, the Company reported that the FDA had accepted the resubmission and assigned a target action date of June 29, 2026, and it repeatedly told investors the resubmission was based on the vendor's progress in resolving FDA-cited deficiencies. Company filings and press releases described the review as on track and advanced commercial launch preparations.

The complaint alleges these statements were materially false and misleading. It claims the Company had not inspected its third-party manufacturing vendor's facility or otherwise audited the facility's compliance with current good manufacturing practices. As a result, the lawsuit alleges Unicycive lacked a reasonable basis to believe the vendor had resolved the FDA's cited deficiencies, and there was an undisclosed risk that the FDA would require additional information about the vendor's manufacturing practices.

Because of these undisclosed facts, the complaint alleges the regulatory approval of OLC was reasonably likely to be delayed, and defendants' positive statements about the Company's business, operations, and prospects lacked a reasonable basis. The lawsuit claims defendants knew or recklessly disregarded that these adverse facts were being concealed from the public while the price of Unicycive securities remained artificially inflated.

The Truth Emerges

Before the market opened on June 30, 2026, Unicycive disclosed that the FDA had issued a second Complete Response Letter regarding the resubmitted NDA for OLC. According to the Company's announcement, the letter was based on the same third-party manufacturing deficiencies that had been identified in the previous CRL issued in June 2025.

The disclosure revealed that the FDA had not yet conducted its inspection of the third-party manufacturing vendor as part of the resubmission review. The complaint alleges this called into question the Company's earlier representations that the vendor had made significant progress toward regaining compliance and that the resubmission was based on progress in resolving the FDA-cited deficiencies. While the Company noted the FDA did not raise concerns about OLC's clinical efficacy or safety data, the persistence of the same manufacturing deficiencies underscored the risk the complaint alleges had been concealed from investors.

Market Reaction

On June 30, 2026, following the disclosure of the second Complete Response Letter, Unicycive's stock price fell $3.01, or 39.1%, to close at $4.69 per share on unusually heavy trading volume. The complaint notes that during the class period the Company's share price had reached a high of $8.56 per share on May 14, 2026, reflecting the artificial inflation the lawsuit alleges resulted from defendants' statements. The complaint alleges the single-day decline erased a substantial portion of that value after the market learned the FDA had again cited the same manufacturing deficiencies.

Next Steps

●       Lead Plaintiff Deadline: November 2, 2026

●       After the lead plaintiff deadline, the Court will consider any lead plaintiff motions. 

●       Defendants may file a motion to dismiss.

●       If the case proceeds, the Court may later consider class certification.

Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. Prior results do not guarantee similar outcomes.