Unicycive: 'Buy' Rating On NDA Resubmission OLC And Potential Best-In-Class Profile

2026-01-29 16:09:40 ET

I'm initiating Unicycive Therapeutics ( UNCY ) with a "Buy" rating, and this is based on its ability to have its resubmission of its New Drug Application [NDA] for oxylanthanum carbonate [OLC] accepted by the FDA for review. This drug is a phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease [CKD] on dialysis. The reason why I believe it deserves this rating is because it is going to be a quicker pathway to approval, if granted this time around. Why is that? That's because the FDA has granted OLC as a Class II complete response, which only stands with a 6-month review time. With that being said, the FDA had set up a Prescription Drug User Fee Act [PDUFA] date of June 29, 2026....

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