Unicycive Therapeutics, Inc.
Case Overview
44 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.
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.