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Unicycive Faces Securities Class Action Over Manufacturing Disclosure Lapses

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Unicycive Faces Securities Class Action Over Manufacturing Disclosure Lapses

New York – September 11, 2026 -- Bronstein, Gewirtz & Grossman, LLC has filed a class action lawsuit against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and certain of its officers, alleging violations of federal securities laws tied to the company's handling of a third-party manufacturing vendor's compliance issues.

Lawsuit covers investors who purchased Unicycive stock between December 29, 2025 and June 29, 2026

The complaint alleges Unicycive failed to inspect or audit its third-party manufacturing vendor's facility for compliance with current good manufacturing practices (cGMP). As a result, the company allegedly lacked a reasonable basis to claim the vendor had remedied deficiencies previously cited by the U.S. Food and Drug Administration.

Complaint claims FDA approval risk for oxylanthanum carbonate was undisclosed

According to the filing, there was a material undisclosed risk that the FDA would demand additional information regarding the vendor's manufacturing practices, making regulatory approval of Unicycive's drug candidate oxylanthanum carbonate reasonably likely to face delay. The complaint alleges that Unicycive's public statements about its business, operations, and prospects during the Class Period were materially false and misleading, or lacked a reasonable basis.

Investors face a November 2, 2026 deadline to seek lead plaintiff status

Investors who suffered losses on Unicycive securities during the Class Period have until November 2, 2026, to request that the court appoint them as lead plaintiff. Bronstein, Gewirtz & Grossman noted that eligibility to share in any potential recovery does not require serving as lead plaintiff. The firm is representing investors on a contingency-fee basis, with fees and expenses reimbursed only in the event of a successful outcome.

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