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Aurinia Pharma Shares Surge 125% On Positive Trial Results For Lupus Drug

Aurinia Pharmaceuticals Inc. (AUPH) stock skyrocketed more than 125% in the extended session on Wednesday after the company announced positive efficacy and safety results from a Phase 3 trial for a drug that treats a common complication of lupus, an autoimmune disease.

The company announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate and low-dose corticosteroids, in the treatment of lupus nephritis.

Lupus nephritis is an inflammation of the kidney caused by Systemic Lupus Erythematosus.

"This extraordinary pivotal data confirms voclosporin's ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care," Chief Medical Officer Neil Solomons said in a statement. "This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death."

Voclosporin was granted Fast Track designation by the FDA in 2016. Aurinia plans to submit an NDA to the FDA in the first half of 2020.

Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027.

AUPH closed Wednesday's trading at $8.39, up $0.41 or 5.14% on the Nasdaq. The stock further rose $10.49 or 125.03% in the after-hours trade.

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