Unicycive Therapeutics Plans To Resubmit NDA For Oxylanthanum Carbonate

(RTTNews) - Unicycive Therapeutics, Inc. (UNCY), Tuesday announced its plan to resubmit the New Drug Application for Oxylanthanum Carbonate or OLC by year-end.

This comes after the company received constructive feedback and detailed meeting minutes from its Type A meeting with the U.S. Food and Drug Administration, which was held to discuss the resolution of the single deficiency identified in the Complete Response Letter related to the compliance status of a third-party manufacturing vendor.

In the meeting, the agency found no other concerns to the company, including pre-clinical, clinical, or safety data submitted as part of the NDA for OLC, an investigational oral phosphate for the treatment of patients with chronic kidney disease on dialysis.

In light of this recent development, the company also expects a PDUFA date in the first half of 2026.

In the pre-market hours, UNCY is trading at $5.11, down 2.48 percent on the Nasdaq.