Unicycive Plunges 17.65% on FDA Rejection

On June 30, 2025, Unicycive's stock experienced a significant drop of 17.65% in pre-market trading.

Unicycive Therapeutics received a Complete Response Letter from the FDA for its Oxylanthanum Carbonate (OLC) New Drug Application (NDA). The FDA cited deficiencies in third-party manufacturing as the reason for the rejection. The company is actively working with its partners to address these concerns and still anticipates a decision by the PDUFA date of June 28, 2025.

Unicycive's response to the FDA's requests and its confidence in meeting the PDUFA date indicate progress toward resolving the issues, which has been reflected in the stock's recovery.