Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced that the first patient has been dosed in AURORA, the Company’s Phase 3 confirmatory clinical trial evaluating voclosporin for the treatment of lupus nephritis (LN), an autoimmune disease caused by lupus that involves extreme inflammation and failure of the kidneys.
“Dosing our first patient today is an important milestone for the Company,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Our Phase 3 trial design is nearly identical to that of our successful Phase 2 AURA trial which demonstrated the potential of voclosporin to increase both speed and rates of remission in patients with active LN. We remain dedicated to advancing this treatment and making a meaningful impact in the lives of patients suffering from LN and those around them.”
AURORA is a 52-week global double-blind placebo controlled study, designed to demonstrate that voclosporin added to the current standard of care of mycophenolate mofetil (MMF) can increase overall renal response rates in the presence of extremely low steroids. The primary endpoint is complete renal response at 52 weeks. This trial will recruit ~320 patients and is intended to support full marketing approval of voclosporin for patients with LN across multiple regulatory jurisdictions.
“Lupus nephritis is a devastating disease which if not managed, can be life-threatening. There is no approved medication to treat the condition which mostly affects women in their childbearing years,” said Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine at University of North Carolina School of Medicine and principal investigator for the study. “The AURA Phase II results showed great promise and if replicated in Phase 3, voclosporin has the potential to change the current treatment paradigm for LN.”
Shares of Aurinia closed today at $7.06, down $0.27 or -3.68%. AUPH has a 1-year high of $10.54 and a 1-year low of $1.74. The stock’s 50-day moving average is $7.10 and its 200-day moving average is $4.63.
On the ratings front, Aurinia has been the subject of a number of recent research reports. In a report issued on April 25, H.C. Wainwright analyst Ed Arce reiterated a Buy rating on AUPH, with a price target of $12, which represents a potential upside of 67% from where the stock is currently trading. Separately, on April 20, Cantor Fitzgerald’s Elemer Piros reiterated a Buy rating on the stock and has a price target of $14.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ed Arce and Elemer Piros have a yearly average return of 27.4% and a loss of 4.4% respectively. Arce has a success rate of 51% and is ranked #120 out of 4566 analysts, while Piros has a success rate of 44% and is ranked #4156.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $12.00 which is 66.7% above where the stock opened today.
Aurinia Pharmaceuticals, Inc. operates as a biopharmaceutical company. It focuses on discovering and developing immunomodulating therapeutics. The company’s pipeline includes voclosporin for the treatment of lupus nephritis.