Aurinia Submits FDA New Drug Admission For Novel Voclosporin Kidney Treatment


Shares in Aurinia Pharmaceuticals, Inc (AUPH) advanced in pre-market trading as the biotech company announced the submission of the New Drug Application (NDA) for its experimental voclosporin drug for the treatment kidney inflammation.

The stock rose 3.1% to $16.75 in pre-market U.S. trading. Aurinia said that the NDA submitted to the U.S. Food and Drug Administration (FDA) is backed by a global clinical program including the pivotal Phase 3 Aurora study and the pivotal Phase 2 Aura LV study.

There are currently no FDA-approved treatments for serious kidney inflammation, also known as lupus nephritis (LN). Voclosporin is a potentially best-in-class calcineurin inhibitor (CNI) and an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney.

“LN is a severe and debilitating consequence of lupus, which can severely impact the quality of life of individuals struggling with this disease,” said Peter Greenleaf, President and CEO of Aurinia. “We are rapidly advancing our U.S. commercial strategy and infrastructure to support a potential launch early next year.”

The Canada-based biotech company added that the NDA submission also includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months.

Shares in Aurinia have dropped 24% so far this year. Five-star analyst Ed Arce at H.C. Wainwright this month reaffirmed his Buy rating on the stock with a bullish $32 price target (97% upside potential).

“With several key appointments to its Board and its senior management team highlighting the ongoing commercial preparations, we expect Aurinia to rapidly take a leading position in the LN market with voclosporin,” Arce wrote in a note to investors. “We estimate an 87.5% probability of approval for voclosporin, with a launch in early 2021 assuming a rather modest 19.6% peak penetration in diagnosed active LN patients.”

Overall, TipRanks data shows that the biotech player is drawing an unanimous bullish outlook from Wall Street. The score of 6 Buy ratings from analysts in the past three months is making the consensus a Strong Buy. The 12-month average price target stands at $25.40, reflecting a 56% upside potential from where the stock is currently trading. (See AUPH stock analysis on TipRanks).

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