Business
Aurinia Reports Second Quarter 2020 Financial Results and Recent Operational Highlights
- U.S. Food & Drug Administration grants Priority Review for voclosporin and sets PDUFA date of January 22, 2021 - - Cash, cash equivalents and short term
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- U.S. Food & Drug Administration grants Priority Review for voclosporin and sets PDUFA date of January 22, 2021 - \n\n\n- Cash, cash equivalents and short term investments totaled approximately $442.06 million at July 31, 2020 - \n\n\n- Conference call and webcast to be hosted today at 4:30pm EDT -\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (Aurinia or the Company) today reported financial results for the second quarter ended June 30, 2020 and provided an update on recent operational highlights.\n\n\n“The acceptance of the voclosporin NDA is a significant step towards our goal of delivering the first FDA-approved therapy specifically for people living with lupus nephritis,” commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. “These people suffer from a debilitating, progressive condition that, if not adequately or quickly controlled, leads to life-threatening end-stage renal disease. Despite its high healthcare burden, lupus nephritis has no approved treatments in the United States which we believe has contributed to low awareness of this condition. Aurinia feels the urgency of its mission to change the course of lupus nephritis for this community in need, by combining deep engagement and advocacy efforts with truly innovative medical science.”\n\n\nIn addition to preparing for the launch of voclosporin for use as a potential treatment for lupus nephritis (LN), Aurinia continues to explore voclosporin in other proteinuric kidney indications and expects to provide an update on a planned clinical development program later this year. The Company’s development of voclosporin ophthalmic solution (VOS) for dry eye syndrome (DES) remains on track to report topline results from its Phase 2/3 AUDREYTM dose-ranging trial during the fourth quarter of 2020.\n\n\nMax Colao, Chief Commercial Officer of Aurinia, commented, “As we make progress on our regulatory submission, we’re rapidly building a world class commercial team that is fully resourced and committed to engaging the lupus nephritis community and healthcare professionals. Our strategy for a successful U.S. launch will be executed by deeply experienced Aurinia specialists and led by a proven leadership team. We are driven to make a difference in the lives of the lupus nephritis patients and our ...