Posted by Michael Wonder on 02 Jul 2026
Unicycive Therapeutics receives complete response letter from FDA regarding resubmitted oxylanthanum carbonate new drug application
30 June 2026 - Unicycive Therapeutics today announced that it has received a complete response letter from the US FDA regarding the resubmitted new drug application for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from Unicycive.
