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The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.
The FDA grants priority review designation to the evaluation of drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment for serious conditions.
The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm.
Clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation 2020 Spring Clinical Meetings.