- Unicycive Therapeutics Inc’s (NASDAQ:UNCY) pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol has met the primary endpoint.
- Renazorb is an investigational phosphate binding agent utilizing proprietary nanoparticle technology under development for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
- It potentially provides benefits over currently available treatment options as it requires fewer pills per dose and is swallowed instead of chewed.
- Also read: Unicycive Therapeutics’ Geographic Atrophy Candidate Shows Improved Contrast Vision In Animal Studies.
- Unicycive previously received confirmatory guidance from the FDA that this single BE study in healthy volunteers would satisfy all clinical regulatory requirements and that no other clinical studies would be required for a New Drug Application (NDA) filing through the 505(b)(2) pathway.
- The results come from a two-way crossover BE study establishing PD BE between Renazorb and Fosrenol. The study enrolled 40 subjects per treatment arm.
- The company expects to file the NDA for Renazorb in mid-2023.
- Price Action: UNCY shares are up 23.88% at $0.83 during the premarket session on the last check Wednesday.
Nasdaq Gains 100 Points; Coca-Cola Earnings Top Expectations
U.S. stocks traded higher toward the end of trading, with the Dow Jones index gaining over 200 points on Tuesday.
The Dow traded up 0.67% to 33,155.68 while the NASDAQ rose 0.78% to 13,120.31. The S&P 500 also rose, gaining, 0.72% to 4,247.52.
