Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) has H.C. Wainwright analyst Ed Arce making a bullish case in a third quarter recap for the drug maker’s prospects at play. In particular, the analyst notes that as the AURORA trial in lupus nephritis (LN) “marches on,” Aurinia is raring to bolster its renal franchise, unleashing new programs in both focal segmental glomerulosclerosis (FSGS) as well as Dry Eye come first quarter of 2018.
Eyeing some compelling pipeline irons in the fire, the analyst reiterates a Buy rating on AUPH stock with a $12 price target, which represents a nearly 139% increase from current levels. (To watch Arce’s track record, click here)
In the worldwide Phase 3 trial of Aurinia’s LN asset voclosporin, the analyst finds progress well “on track” from enrollment completion in the back half of next year to topline readout expected in the back half of 2019.
Arce highlights, “As a reminder, the results from this pivotal study, together with the data from the Phase 2b AURA-LV study, are expected to be sufficient for NDA submissions with the FDA, EMA and PMDA. Based on the robust results of AURA, we have a high degree of confidence in a positive readout from AURORA, especially given that the trial design and endpoints are essentially identical to AURA, except for the treatment duration to primary endpoint (52 weeks vs. 24 weeks) and the number of patients (about 320 vs. 265). With fast-track designation, the company plans to use a rolling NDA process, with the first non-clinical module submitted in 2H18. The projected commercial launch of voclosporin for LN is in early 2021, in-line with our forecast. Due to rapid disease control, lower steroid burden and convenient treatment regimen, we continue to believe in a significant market potential of voclosporin in LN.”
Moving forward, the analyst looks ahead to the drug maker’s expansion in its voclosporin renal franchise as something that “could lead to meaningful value creation for voclosporin and optimally leverage Aurinia’s expertise in renal diseases.”
Worthy of note, this biotech player has earned unanimous approval on the Street, with TipRanks analytics demonstrating AUPH as a Strong Buy. Based on 4 analysts polled by TipRanks in the last 3 months, all 4 rate a Buy on Aurinia stock. The 12-month average price target stands at $11.63, marking a 130% upside from where the stock is currently trading.