Robbins LLP said a securities class action has been filed for investors who purchased or otherwise acquired Unicycive Therapeutics securities from December 29, 2025, through June 29, 2026. The clinical-stage biotechnology company develops therapies for kidney diseases, including oxylanthanum carbonate (OLC), for which it submitted a New Drug Application (NDA) to the FDA (U.S. drug regulator) in September 2024. The FDA accepted the application in November 2024 but issued a Complete Response Letter (CRL, an FDA request for corrective action or information) in June 2025 citing deficiencies at a third-party manufacturing vendor. After a Type A meeting with the FDA in October 2025, Unicycive resubmitted the NDA in December 2025. The complaint alleges the company did not inspect or audit the vendor's facility, lacked a reasonable basis to believe the deficiencies had been resolved, and failed to disclose risks that further FDA information requests could delay OLC approval. On June 30, 2026, Unicycive disclosed that the FDA's new CRL cited the same vendor deficiencies, sending the stock down $3.01, or 39.1%, to $4.69 on heavy volume. The lead plaintiff deadline is November 2, 2026; participation is on a contingency-fee basis and does not require investors to seek lead plaintiff status.