UNCY - Unicycive jumps 25% as kidney disease drug meets main goal in key trial
- Nano-cap biotech Unicycive Therapeutics ( NASDAQ: UNCY ) added ~25% pre-market Wednesday after announcing that its pivotal bioequivalence (BE) study for kidney disease therapy Renazorb met the primary goal.
- Renazorb is an oral phosphate-binding agent targeted at hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
- Based on topline data, the trial has confirmed the pharmacodynamic BE of Renazorb to Takeda's ( TAK ) rival hyperphosphatemia therapy Fosrenol. The company said that, therefore, the study met the regulatory criteria for PD BE in the healthy volunteer BE study.
- "This is a major milestone for Unicycive that brings us one step closer to obtaining market approval for Renazorb to treat hyperphosphatemia," Chief Executive of Unicycive ( UNCY ) Shalabh Gupta remarked.
- The company expects to file a New Drug Application (NDA) for Renazorb in mid-2023 "and for its potential approval in order to benefit the multitude of hyperphosphatemia patients who are not well served by current treatment options," Gupta added.
- In July, Lee's Pharmaceutical (HK), a unit of Chinese biopharma Lee's Pharmaceutical Holdings, agreed to develop, market, and commercialize Renazorb in Asia.
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Unicycive jumps 25% as kidney disease drug meets main goal in key trial