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.
Unicycive Therapeutics IncFDA issued a second Complete Response Letter for OLC NDA due to manufacturing deficiencies, causing stock decline and triggering securities fraud investigation.