Shares of Aurinia Pharmaceuticals Inc. (AUPH) are gaining about 11% on the Nasdaq. The other day, the U.S. Food and Drug Administration accepted the filing of the company's New Drug Application for voclosporin, a potential treatment for lupus nephritis.
AUPH is currently trading at $16.00, up $1.52 or 10.50%, on the Nasdaq.
The FDA has granted priority review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act target action date of January 22, 2021.
Lupus nephritis is a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
"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, President and Chief Executive Officer 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."
For comments and feedback contact: editorial@rttnews.com
Business News
December 26, 2025 08:42 ET Third quarter economic growth data from some major economies including the U.S. were the main news in this holiday shortened week. GDP growth and industrial production data from the U.S. helped to boost morale, while the consumer confidence survey results were less upbeat. In Europe, the quarterly economic growth data from the U.K. drew attention, while the minutes of the Australian central bank’s latest policy session was in focus in Asia.