Aurinia Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved its Lupkynis (voclosporin) treatment for use in adult patients with active lupus nephritis (LN), an autoimmune kidney disease.
The FDA approval was granted for Aurinia’s (AUPH) Lupkynis oral therapy to be used in combination with an immunosuppressive therapy regimen. It marks the first FDA-approved oral therapy for LN, which causes irreversible kidney damage and raises the risk of kidney failure, cardiac issues, and death. Following the approval, Lupkynis will now be available to patients in the US.
Lupus nephritis (LN) is a progression of systemic lupus erythematosus (SLE), a chronic autoimmune disease. About 200,000-300,000 people have SLE in the US and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis.
“The Lupkynis approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition,” said Aurinia CEO Peter Greenleaf. “The approved label supports the efficacy and safety of Lupkynis as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of Lupkynis.”
According to pivotal trials, patients treated with Lupkynis in combination with standard-of-care (SoC) were more than twice as likely to achieve renal reaction and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients with SoC alone, the company said. UPCR is a standard measurement used to monitor protein levels in the kidney.
On a one-year basis, the stock is now trading down 19%, yet the Street has a bullish Strong Buy consensus on Aurinia. That’s with 6 recent Buy ratings. The average analyst price target of $26.40 indicates upside potential of 78% lies ahead.
Ahead of the FDA approval, Cohen & Co. analyst Ken Cacciatore said that the US regulator’s call would position Aurinia for a “meaningful inflection” and he therefore selected the stock as a “best idea” for 2021.
Cacciatore reiterated a Buy rating on the stock with a $30 price target as he is impressed with voclosporin’s efficacy and safety combined with an unmet clinical need.
The analyst has “strong conviction” that the therapy should be “rapidly incorporated” into the standard of care. He expects voclosporin to generate more than $1 billion in sales. (See AUPH stock analysis on TipRanks).
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