Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) just scored what H.C. Wainwright Ed Arce considers “a major win for Aurinia,” particularly following “much investor consternation” circling the death toll at the biotech firm’s 6-month primary readout of its Phase 2b AURA-LV trial. As of the close of the firm’s end-of-Phase 2 (EOP2) meeting with the FDA, the agency announced as of November 2nd that it has permitted a single Phase 3 trial in support of an NDA for voclosporin, the firm’s potential new therapy option for people with active lupus nephritis (lupus-related kidney disease).

In reaction to the results of the EOP2 meeting, which the analyst praises as “better than we could have hoped for,” he reiterates a Buy rating on shares of AUPH with a $10 price target, which represents a 295% increase from current levels.

To Arce, these results “not only fully validate the company’s view of that study’s robustly positive results, but also provide for some unexpected elements to the Phase 3 protocol that, in our view, have the effect of further mitigating the risk of achieving a positive pivotal readout.”

After reflecting upon meetings with AUPH management, the analyst believes that the “FDA does not appear overtly concerned with the death rate or the company’s site selection tactic for Phase 3.”

Singing the praises of the firm, Arce asserts that “taken as a whole, the AURORA study design is not only likely to lead to a statistically significant positive primary endpoint, but also a more robust result (a greater separation from placebo) than AURA-LV.”

Ultimately, “We continue to believe that AUPH shares are significantly undervalued and recommend that investors consider taking or adding to their positions ahead of the initiation of AURORA,” the analyst concludes.

As usual, we like to include the analyst’s track record when reporting on new analyst notes to give a perspective on the effect it has on stock performance. According to TipRanks, five-star analyst Ed Arce is ranked #330 out of 4,162 analysts. Arce has a 25% success rate and realizes 11.7% in his yearly returns. However, when recommending AUPH, Arce loses 16.9% in average profits on the stock.

TipRanks analytics exhibit AUPH as a Strong Buy. Based on 5 analysts polled in the last 3 months, 100% rate a Buy on AUPH. The 12-month price target stands at $9.00, marking a 250% upside from where the shares last closed.