Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced that it has selected Worldwide Clinical Trials as its Clinical Research Organization (CRO) for the AURORA Phase 3 study of volcosporin for the treatment of active lupus nephritis (LN).
“Selecting a CRO for AURORA is a key milestone for Aurinia following our successful end-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) Division of Pulmonary, Allergy and Rheumatology Products. We are thrilled to partner with Worldwide to support the AURORA Phase 3 clinical trial,” said Charles Rowland, Chief Executive Officer of Aurinia. “We are rapidly moving forward with our plans to bring this important therapy to market for patients living with this devastating disease, and Worldwide’s deep expertise and capabilities in managing pivotal trials will be a tremendous asset to us. We are on track to commence the AURORA trial in the second quarter of 2017, and we expect the results from this study will support a New Drug Application (NDA) submission to the FDA.”
With support from Worldwide, Aurinia will proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients. The primary endpoint as in the Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Therefore, secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN.
“Our entire Worldwide team is delighted to have been selected as Aurinia’s CRO partner to advance voclosporin, which has the potential to become the first FDA-approved treatment for LN,” said Peter Benton, President and Chief Operating Officer at Worldwide Clinical Trials. “We’re truly honored that an innovator like Aurinia recognizes what Worldwide brings to the table: medical and scientific expertise, proactive insight, dogged determination, rigorous processes and a commitment to getting it right. We’re looking forward to working closely with Aurinia’s clinical development team on this new therapy, which could significantly improve the lives and long-term outcomes of patients suffering from LN.”
Shares of Aurinia Pharmaceuticals are up over 13% to $3.46 in pre-market trading Friday. AUPH has a 1-year high of $5.69 and a 1-year low of $1.74. The stock’s 50-day moving average is $2.50 and its 200-day moving average is $2.89.
On the ratings front, Aurinia has been the subject of a number of recent research reports. In a report issued on January 25, FBR analyst Vernon Bernardino reiterated a Buy rating on AUPH, with a price target of $9.00, which implies an upside of 195% from current levels. Separately, on December 30, H.C. Wainwright’s Ed Arce maintained a Buy rating on the stock and has a price target of $8.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Ed Arce have a yearly average loss of 21.4% and a return of 8.4% respectively. Bernardino has a success rate of 21% and is ranked #4316 out of 4378 analysts, while Arce has a success rate of 37% and is ranked #759.
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 $7.50 which is 146% above where the stock closed yesterday.
Aurinia Pharmaceuticals, Inc. operates as a biopharmaceutical company. It focuses on discovery and development of immunomodulating therapeutics. Its products include voclosporin and non-immunosuppressive cyclosporine analogue molecules for the treatment of lupus nephritis.