Unicycive Therapeutics (UNCY) announced on Thursday that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for its kidney disease therapy oxylanthanum carbonate (OLC).
In late June, the FDA declined to approve the oral phosphate
This was corrected on 01/29/2026 at 10:59 AM. This story has been amended to reflect a newly-issued press release from Unicycive which indicated June 29, 2026 as the corect PDUFA date for NDA. A previous version of the story mentioned it as June 27 based on earlier release.