Unicycive Therapeutics shares rose after the company said the Food and Drug Administration has accepted the resubmission of its New Drug Application for oxylanthanum carbonate.
The stock was 5% higher, at $4, in morning trade, but is down 19% in the past 12 months.
Oxylanthanum carbonate is the company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
The biotechnology company said the NDA was resubmitted following a Complete Response Letter received in June.
The FDA has deemed the resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act target action date of March 25, 2027.
Unicycive said it doesn't know whether the FDA will decide to conduct a pre-approval inspection of the new third-party drug product vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice, it plans to seek FDA alignment on a shorter approval timeline.
The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA, the company said.
Comments