Aurinia Pharmaceuticals management to meet virtually with Cantor Fitzgerald » 17:0107/0907/09/20
Virtual Meeting to be…
Virtual Meeting to be held on July 13 hosted by Cantor Fitzgerald.
Aurinia Pharmaceuticals participates in a conference call with Cowen » 17:0007/0907/09/20
Pharmaceutical Analyst Cacciatore holds a conference call with management on July 16 at 11 am hosted by Cowen.
|Over a week ago|
Aurinia Pharmaceuticals completes enrollment in Phase 2/3 AUDREY trial » 06:1606/2206/22/20
Aurinia Pharmaceuticals announced it has completed enrollment for the Phase 2/3 AUDREY clinical trial evaluating voclosporin ophthalmic solution for the potential treatment of dry eye syndrome, a chronic disease estimated to affect more than 16M people in the United States.
Aurinia Pharmaceuticals initiated with a Buy at BTIG » 19:3306/1606/16/20
BTIG analyst Dae Gon Ha…
BTIG analyst Dae Gon Ha initiated coverage of Aurinia Pharmaceuticals with a Buy rating and $20 price target. The analyst cites positive topline results from Phase 3 AURORA lupus nephritis, or LN, study that "pushed voclosporin one-step closer to commercialization", adding that limited competition in LN, attractive safety/efficacy profile of voclosporin, and the dry eye syndrome opportunity warrant a positive view on the stock.
|Over a month ago|
Aurinia Pharmaceuticals presents additional AURORA trial safety data » 06:0806/0906/09/20
Aurinia Pharmaceuticals announced that additional safety data from the completed AURORA pivotal trial of voclosporin were shared at the European Renal Association-European Dialysis and Transplant Association 2020 Virtual Congress in an oral presentation given by nephrologist Dawn Caster, M.D., Assistant Professor of Medicine at the University of Louisville School of Medicine. The data showed that pre-specified confirmed estimated glomerular filtration rate 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. eGFR is a standard measure of kidney function. No clinically meaningful differences between the treatment and control groups were seen at any timepoints in the study on this parameter or in serum creatinine levels, another biomarker for renal damage. All patients in the AURORA study were treated with mycophenolate and a background of corticosteroids. MMF is considered the standard-of-care for lupus nephritis, although unapproved by the FDA for that use.
Aurinia Pharmaceuticals presents new subgroup analyses from AURORA trial » 07:1606/0506/05/20
Aurinia Pharmaceuticals announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented. The data were shared at the European League Against Rheumatism, or EULAR, 2020 E-Congress in an oral presentation. The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race. Significant renal response rates were seen for Hispanic/Latino patients in the voclosporin arm versus control arm, as well as for non-Hispanic/Latino patients in the voclosporin arm versus the control arm. Furthermore, all other pre-specified subgroup analyses favored voclosporin.
Aurinia Pharmaceuticals files $500M mixed securities shelf 16:1005/2905/29/20
Aurinia Pharmaceuticals completes submission of NDA to FDA for voclosporin » 06:0605/2605/26/20
Aurinia Pharmaceuticals announced the completion of the rolling submission of a New Drug Application to the United States FDA for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus. There are currently no FDA-approved treatments for LN. The NDA submission includes a request for Priority Review, which, if granted, would shorten the FDA's review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months.
Fly Intel: After-Hours Movers » 19:1105/1405/14/20
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Aurinia reports Q1 EPS (15c), consensus (15c) » 16:0305/1405/14/20
Reports Q1 revenue…
Reports Q1 revenue $30,000, consensus $50,000. "We are fortunate that the global COVID-19 pandemic has had minimal impact on Aurinia's operations, and we have maintained our timelines to ensure the filing of the voclosporin NDA by the end of the second quarter and hopefully obtain approval in early 2021," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Following the positive AURORA data reported last December we have strengthened the balance sheet, added world-class commercial expertise including the appointments of Timothy, Max, and Joe, and on-boarded a group of extraordinarily talented commercial leaders and additional staff." Greenleaf further stated, "With the establishment of our commercial hub in Maryland, we're building and preparing for the U.S. launch of voclosporin as the first FDA-approved treatment for lupus nephritis. In addition, the VOS development program remains on target, and we anticipate reporting out top-line results from the Phase 2/3 AUDREY dose-ranging trial of VOS during the fourth quarter of this year." Dr. Neil Solomons, Chief Medical Officer of Aurinia commented, "With respect to FSGS, our exploratory study has been open for an extended period and due to the continued difficulty identifying and enrolling primary FSGS patients, we've decided to adjust our approach. We are preparing to evaluate voclosporin in other proteinuric kidney diseases, while continuing to support patients who have participated in the FSGS exploratory study. As we work to incorporate these broader populations further updates will be available later this year."