Business
Aurinia Reports Fourth Quarter and Full Year 2019 Financial Results and Operational Highlights
- Cash and cash equivalents totaled approximately $306 million at December 31, 2019 - - Positive AURORA Phase 3 results with voclosporin enabling an NDA
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Cash and cash equivalents totaled approximately $306 million at December 31, 2019 -\n\n\n- Positive AURORA Phase 3 results with voclosporin enabling an NDA submission for the treatment of lupus nephritis (“LN”) by the end of the second quarter 2020 -\n\n\n- Continued build out of a top-tier commercial team, highlighted by the appointment of Max Colao, Chief Commercial Officer, focused on launch activities -\n\n\n- AUDREY Phase2/3 Dry Eye Study remains on-track with results anticipated during the second half of 2020 -\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX: AUP) (“Aurinia” or the “Company”) today issued its financial results for the fourth quarter and year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in U.S. dollars.\n\n\n“2019 was a truly transformational year for Aurinia, highlighted by the positive results achieved with voclosporin in the Phase 3 AURORA clinical trial for the treatment of LN. As the team works diligently to prepare and file a New Drug Application to the U.S. FDA next quarter, we continue to build out an incredibly talented and experienced commercial team that will be led by Max Colao, Aurinia’s newly appointed Chief Commercial Officer,” commented Peter Greenleaf, President and Chief Executive Officer of Aurinia.\n\n\n“Beyond the impact voclosporin could bring to those living with LN, we continue to evaluate voclosporin in additional indications, including the rare kidney disease, FSGS, as well as for the potential management of dry eye syndrome. During the second half of 2020, we anticipate reporting new data from both of these development programs, consisting of interim data from the exploratory Phase 2 FSGS study and results from the Phase 2/3 AUDREY DES trial evaluating 3 concentrations of VOS compared to vehicle alone,” said Neil Solomons, Chief Medical Officer of Aurinia.\n\n\nRecent Operational Highlights\n\n\nPre-NDA Meeting with the U.S. Food & Drug Administration (“FDA”)\n\n\nAurinia held a positive and successful Pre-NDA meeting with the FDA Division of Pulmonary, Allergy and Rheumatology Products on February 25, 2020. The Company presented information about the safety and efficacy data to be included in the filing, reviewed the format and content of the planned application, and gained agreement on the roll...