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 IncFDA issued second Complete Response Letter for OLC NDA, citing manufacturing deficiencies, causing stock decline.