What Happened?

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, thereby injuring investors.

What Is The Lawsuit About?

The complaint filed in this class action alleges that throughout 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 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) 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.