Unicycive Therapeutics approval delay ‘not a surprise,’ says Noble Capital

The receipt of a Complete Response Letter in response to Unicycive’s New Drug Application for Oxylanthanum Carbonate was expected following the announcement earlier this month stating that the FDA manufacturing inspection had found deficiencies with one of the OLC contract manufacturers, Noble Capital tells investors in a research note. Unicycive plans to hold a Type A meeting with the FDA to determine its requirements for resolution of the issues cited in the CRL, the firm says, adding that resolving the manufacturing issues should allow prompt approval. Noble has an Outperform rating and $60 price target on the shares, which accounts for the 1-for-10 reverse split earlier this month and delaying the product launch until 1H26.