Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced that it has received the final End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug Administration Division of Pulmonary, Allergy and Rheumatology Products. The minutes are consistent with the preliminary responses that were issued to the Company prior to the meeting which took place on October 25, 2016.
As previously communicated, Aurinia will be conducting a single, Phase 3 clinical trial assessing 23.7mg BID for the treatment of active lupus nephritis (LN). The trial, which will be known as AURORA, will be a 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.
Aurinia believes this Phase 3 clinical trial will support a New Drug Application (NDA) submission.
“We have thoroughly reviewed the final EOP2 meeting minutes provided to us by FDA, which are consistent with our previous assessment and are moving as quickly as we can to initiate the AURORA trial,” commented Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia.”
“We are pleased to be working closely with FDA to bring this treatment to market and helping as many people as possible suffering from this debilitating disease,” added Charles Rowland, Aurinia’s Chief Executive Officer. “Our clinical team has been working on preparations for this important trial to meet our goal of enrolling the first patient in Q2 2017. In the meantime, we expect the AURA 48-week secondary endpoint durability of renal response data in Q1 next year.” (Original Source)
Shares of Aurinia are currently trading at $2.76, up $0.03 or 1.10%. AUPH has a 1-year high of $5.69 and a 1-year low of $1.42. The stock’s 50-day moving average is $3.09 and its 200-day moving average is $2.97.
On the ratings front, AUPH stock has been the subject of a number of recent research reports. In a report issued on November 16, Leerink Swann analyst Joseph Schwartz reiterated a Buy rating on AUPH, with a price target of $7.00, which implies an upside of 133% from current levels. Separately, on November 7, H.C. Wainwright’s Ed Arce reiterated a Buy rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Schwartz and Ed Arce have a yearly average return of 2.5% and 1.8% respectively. Schwartz has a success rate of 44% and is ranked #1212 out of 4269 analysts, while Arce has a success rate of 31% and is ranked #1720.
Overall, 5 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 $7.00 which is 133.3% above where the stock opened today.
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.