A securities class action has been filed against Unicycive Therapeutics, Inc. (UNCY) on behalf of persons and entities that purchased or otherwise acquired Unicycive securities between December 29, 2025 through June 29, 2026. This case has been filed in the USDC – NDCA.
Unicycive is a clinical-stage biotechnology company, identifies, develops, and commercializes therapies for the treatment of kidney diseases.
Unicycive submitted a New Drug Application (“NDA”) for its kidney disease therapy, oxylanthanum carbonate (“OLC”), to the U.S. Food and Drug Administration (“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.
The compalint alleges that hroughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, 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 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.