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Case Overview

38 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline:Lead Plaintiff Deadline:11/02/2026
Status:Status:Investigating
Company Name:Company Name:Unicycive Therapeutics, Inc.
Court:Court:Northern District of California
Case Number:Case Number:3:26cv09559
Class Period:Class Period:12/29/2025 - 06/29/2026
Ticker:Ticker:UNCY
Related Attorneys:Lead Attorneys:Thomas W. Elrod
Related Practices:Related Practices:Securities
The lawsuit alleges that Unicycive made false and/or misleading statements and failed to disclose to investors that: (i) the Company had not inspected its third-party manufacturing vendor’s facility or otherwise audited the facility’s compliance with current good manufacturing practices; (ii) as a result, the Company lacked a reasonable basis to believe that the vendor had resolved the FDA’s cited deficiencies; (iii) there was an undisclosed risk that the FDA would require additional information about the vendor’s facility’s manufacturing practices; and (iv) as a result of the foregoing, the regulatory approval of oxylanthanum carbonate (“OLC”), a kidney disease therapy, was reasonably likely to be delayed.
 
On June 30, 2026, Unicycive disclosed that the FDA had issued a second Complete Response Letter regarding the Company’s resubmitted New Drug Application 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.

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