Unicycive Therapeutics Faces Class Action Over FDA Compliance Claims

The litigation targets the period between December 29, 2025, and June 29, 2026, during which Unicycive shares reached a high of $8.56. Shareholders claim the company repeatedly signaled confidence in the approval of its oxylanthanum carbonate New Drug Application based on nothing more than its own assumptions. When the FDA issued a second Complete Response Letter citing the same manufacturing deficiencies identified a year earlier, the stock plummeted $3.01 in a single session to close at $4.69.

Attorney Joseph E. Levi, whose firm Levi & Korsinsky is representing the plaintiffs, argues that the company’s failure to inspect the vendor’s facility deprived investors of a clear understanding of the risks involved. The lawsuit asserts that the company lacked a reasonable basis for the optimistic statements made leading up to the PDUFA target date. Investors who purchased shares during the specified window and suffered losses have until November 2, 2026, to seek appointment as lead plaintiff in the case.