Block & Leviton is investigating whether Unicycive Therapeutics, Inc. made false or misleading statements or failed to disclose material information to investors regarding the FDA's review of its OLC New Drug Application. On June 30, 2026, the company announced that the FDA had issued a second Complete Response Letter based on the same third-party manufacturing deficiencies flagged in a prior letter from June 2025, and that it understood the FDA had not yet inspected the manufacturing vendor as part of the resubmitted application's review — news that was followed by a decline in the company's stock price.
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