Unicycive Successfully Raises $130M To Launch Renazorb For Dialysis Patients

Unicycive Therapeutics, Inc., (Nasdaq: UNCY) has raised up to $130M to support its New Drug Application (NDA) submission with the FDA for approval and potential commercial launch of Renazorb for the treatment of hyperphosphatemia.

The securities purchase agreement includes initial upfront funding of $30M and up to an additional $100M tied to achievement of milestones.

Highlights

• Unicycive is on track to file a New Drug Application (NDA) for Renazorb marketing approval with the FDA in mid-2023.
• The funding is being led by Vivo Capital with participation from RA Capital, BVF Partners, Logos Capital, and is supported by existing investors Nantahala Capital Partners and Rosalind Advisors Inc.
• Gaurav Aggarwal, M.D., Managing Director of Vivo Capital, will join the Unicycive Board of Directors.
• In December 2022, the company met its primary endpoint in its pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol®.
• The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023.

Lead investor, Vivo Capital, believes that phosphate lowering agents currently on the market do not currently serve dialysis patients well, due to high pill burden and suboptimal tolerability profiles. Renazorb is a phosphate binder that potently controls phosphate with three small tablets per day.

Unicycive stock rose 153% in intra-day trading following the announcement.