Unicycive Resubmits Drug Application, Price Target $22
Unicycive's lead candidate oxylanthanum carbonate, a novel oral phosphate binder for hyperphosphatemia in CKD patients on dialysis, was resubmitted after a Complete Response Letter tied solely to third-party manufacturing issues, with no safety or efficacy concerns, and has been accepted for standard six-month FDA review with a PDUFA date of June 29, H.C. Wainwright tells investors in a research note. The firm, which maintains a Buy rating and $22 price target on the stock, remains bullish on the upcoming PDUFA and recommends taking advantage of any stock weakness prior to approval.
