Robbins LLP is Investigating Allegations that Unicycive Therapeutics, Inc. (UNCY) Misled Investors Regarding the FDA’s Previously Noted Deficiencies at its Third-Party Vendor’s Manufacturing Facility

Robbins LLP informs 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.

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 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.

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 during the applicable Class Period. If you purchased Unicycive Therapeutics, Inc. during this period and suffered investment losses, you may have rights under the federal securities laws. Submit a form for information.

Attorney Advertising. Past results do not guarantee a similar outcome.