Shares in Aurinia Pharma (AUPH) surged 9% in Tuesday’s extended trading after the U.S. Food and Drug Administration (FDA) accepted the filing of its New Drug Application (NDA) for voclosporin, a potential treatment for lupus nephritis (LN). This is a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE).
Encouragingly, the FDA granted a faster six-month Priority Review for the application (instead of the usual ten months), with a PDUFA decision date set for January 22, 2021.
The FDA also told Aurinia that they are not currently planning to hold an advisory committee meeting to discuss the application. The FDA can change this decision based on review of the pending NDA.
“People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, CEO of Aurinia. “We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.”
Voclosporin, an investigational immunosuppressant, is a novel and potentially best-in-class calcineurin inhibitor (CNI) with clinical data in over 2,600 patients across indications, Aurinia says.
The NDA for voclosporin is supported by data from a substantial global clinical program including two pivotal studies, Phase 3 AURORA and Phase 2 AURA-LV.
Shares in Aurinia are trading down 28% year-to-date, yet analysts have a bullish Strong Buy consensus on the stock with 7 back-to-back buy ratings. Meanwhile the average analyst price target stands at $24.50 (69% upside potential). (See AUPH stock analysis on TipRanks).
HC Wainwright analyst Ed Arce reiterated his buy rating on the stock and $32 price target after Aurinia presented new patient subgroup data from the Phase 3 AURORA pivotal trial.
“All pre-specified subgroup analyses of LN patients based on age, sex, race, biopsy class, region, and prior mycophenolate mofetil (MMF) use favored voclosporin over an active control of current standard of care of MMF and low-dose corticosteroids in the AURORA trial” Arce told investors on June 5.
As a result the analyst continues to view the robustness of renal response across race and ethnicity, as well as the rapid onset of effect, as key points of clinical differentiation likely to drive physician uptake of voclosporin as the new standard of care (SOC) regimen for LN.
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