aibioUnicycive discloses securities class action over oxylanthanum carbonate statements
Tickers UNCY
Unicycive said a securities class action was filed in the Northern District of California against the company and certain of its officers, who are not named. The suit concerns statements about its oxylanthanum carbonate application. The company calls the claims meritless.
Key facts
- Company
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY)
- News type
- Legal
- Primary source
- Unicycive Therapeutics, Inc. Form 8-K filed August 18, 2025 (SEC EDGAR)
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) disclosed in a Form 8-K filed August 18, 2025 that a securities class action has been filed against the company and certain of its officers. The defendants named in the filing are Unicycive Therapeutics, Inc. and certain of its officers. The 8-K does not name the individual officers. Shalabh Gupta, the chief executive officer, signed the report on August 18, 2025, but the filing does not say whether he is one of the defendants. The company said it became aware of the suit on August 15, 2025.
The suit was filed in the United States District Court for the Northern District of California. The 8-K describes it as a lawsuit "purporting to be a securities class action." The filing gives no class period, case number or plaintiff name. The claims, as the company describes them, allege violations of the federal securities laws in connection with public statements the company made about its new drug application for oxylanthanum carbonate, or OLC. These are allegations, not findings. The company says it believes the claims are meritless and intends to defend the lawsuit vigorously. The report was filed under Item 8.01, other events.
The application at the center of the suit
OLC is a phosphate binder for hyperphosphatemia in adults with chronic kidney disease on dialysis. The company's 2024 annual report on Form 10-K says the application is submitted under the 505(b)(2) pathway and carries a Prescription Drug User Fee Act date of June 28, 2025. The 8-K does not mention any FDA action on the application.
The annual report says the application rests on three clinical studies: a first-in-human Phase I study in healthy volunteers, a bioequivalence study in healthy volunteers, and a pivotal Phase 2 tolerability study in dialysis patients. The pivotal study was open-label, single-arm and multicenter. It enrolled 106 patients. Of those, 86 entered titration and were counted as the safety population, 78 entered maintenance, and 7 of the 78 did not reach phosphate control. That left 71 patients in the evaluable population, against a planned enrollment of 60. The trial had no control arm, so it cannot show how OLC compares with another binder.
The annual report also says that in March 2025 the FDA conducted a general surveillance inspection of Shilpa Medicare Ltd, at which the company received one procedural observation on Form 483. The filing does not say how that observation affects the application.
The company's finances
For 2024 the company reported a net loss of $36.7 million and an accumulated deficit of $101.3 million at December 31, 2024. The annual report says the company expects to keep incurring losses and will need to raise additional capital to complete planned clinical trials, pursue product development and reach markets for its products. It names equity offerings, debt financing and corporate collaborations as possible sources.
A securities suit adds a cost that the annual report does not quantify. The filing does not estimate legal expenses, a damages range or any insurance coverage for the case.
What comes next
The 8-K gives no schedule for the case, and the company has not said when it will file a response. The next public records will be the court docket, any amended complaint and the company's next periodic report. The claims are unproven allegations, and the 8-K says only that the company will defend the case.