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Will Aurinia Pharma's Lupus Nephritis Drug Pass FDA Muster?

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Shares of Aurinia Pharmaceuticals Inc. (AUPH) have fallen nearly 35% from their 52-week high of $20.48 recorded on Feb.21, 2020, and trade around $13.

Aurinia is a late-stage clinical biopharmaceutical company focused on developing Voclosporin into a potentially groundbreaking therapeutic for lupus nephritis.

Lupus nephritis is an inflammation of the kidney caused by Systemic Lupus Erythematosus. In patients with lupus nephritis, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced eGFR (estimated glomerular filtration rate) and increased serum creatinine levels.

It is estimated that lupus nephritis affects about 200,000 people in the U.S. Historically, high-dose corticosteroids, sometimes in combination with immunosuppressive drugs have been used to treat lupus nephritis.

Aurinia's Voclosporin is a calcineurin inhibitor. By inhibiting calcineurin, Voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. Podocytes are highly specialized cells of the kidney glomerulus that play an important role in glomerular function.

In a clinical trial, the patients who received Voclosporin were 2.65 times more likely to meet the criteria for response based on proteinuria and eGFR. The FDA is currently reviewing Voclosporin and a decision is expected on January 22, 2021.

If approved, Voclosporin will be the second drug to be prescribed for the treatment of lupus nephritis. GlaxoSmithKline plc's (GSK) BENLYSTA is the first and only approved drug for this indication so far. BENLYSTA was approved in the U.S. on December 17, 2020.

Last month, Aurinia entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of Voclosporin for the treatment of Lupus Nephritis in the European Union, Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Otsuka is planning to seek approval for Voclosporin in the EU in the second quarter of 2021 and in Japan next.

Aurinia's cash and equivalents totaled $421 million as of September 30, 2020, which is expected to be sufficient to fund operations through 2022.

AUPH has traded in a range of $9.83 to $20.48 in the last 1 year. The stock closed Friday's (Jan.8, 2021) trading at $13.40, up 1.59%.

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