Unicycive Therapeutics Inc

Block & Leviton is investigating Unicycive Therapeutics for potential securities law violations. The investigation concerns whether the company made false or misleading statements or failed to disclose material information about the FDA review of its OLC New Drug Application. On June 30, 2026, Unicycive announced a second Complete Response Letter from the FDA for the resubmitted OLC NDA, citing the same third-party manufacturing deficiencies identified in a prior Complete Response Letter in June 2025, and that the FDA had not yet inspected the third-party vendor. Following this news, Unicycive's stock price declined. Investors who purchased Unicycive common stock and have seen their shares fall may be eligible to participate in any potential recovery action.

The law firm Kirby McInerney LLP is investigating Unicycive Therapeutics on behalf of investors concerning possible violations of federal securities laws. The investigation follows Unicycive's June 30, 2026 announcement that the FDA issued a second Complete Response Letter for its kidney disease therapy drug application, citing the same third-party manufacturing deficiencies identified in a prior June 2025 letter. On that news, Unicycive's share price fell $3.01, or approximately 39%, from $7.70 on June 29, 2026 to close at $4.69 on June 30, 2026. No lawsuit has been filed at this stage, and the investigation is ongoing to determine whether claims may be brought.

Bragar Eagel & Squire, P.C. is investigating potential claims against Unicycive Therapeutics, Inc. on behalf of Unicycive stockholders. The investigation concerns whether Unicycive violated federal securities laws or engaged in other unlawful business practices. The inquiry follows Unicycive's June 30, 2026 announcement that the FDA issued a second Complete Response Letter for its kidney disease therapy application, citing the same third-party manufacturing deficiencies as a prior letter. On that news, Unicycive shares fell $3.01, or approximately 39%, from $7.70 on June 29 to close at $4.69 on June 30, 2026. Investors who purchased or acquired Unicycive stock and suffered losses are encouraged to contact the firm.

Johnson Fistel, PLLP is investigating Unicycive Therapeutics on behalf of investors who suffered losses, following the company's disclosure that the FDA issued a second Complete Response Letter regarding its resubmitted OLC NDA. The CRL, announced on June 30, 2026, cited the same third-party manufacturing deficiencies identified in the prior June 2025 CRL, and Unicycive noted the FDA had not yet inspected the third-party vendor. Unicycive's stock price declined after the news. The investigation focuses on whether Unicycive made false or misleading statements or failed to disclose material information.

Unicycive Therapeutics received a Complete Response Letter from the FDA for its resubmitted New Drug Application for oxylanthanum carbonate, a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA raised no concerns about clinical efficacy or safety and requested no additional data. The letter cites the same third-party manufacturing deficiencies that led to a previous Complete Response Letter in June 2025, and the FDA has not yet inspected that vendor. Unicycive had resubmitted the application based on the vendor's progress in resolving the deficiencies, which was discussed at a Type A meeting with the FDA in September 2025 where no new issues were raised.