Please ensure Javascript is enabled for purposes of website accessibility

Why Aurinia Pharmaceuticals Is Up Today

By Prosper Junior Bakiny – Jul 22, 2020 at 11:31AM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The FDA granted priority review to one of the company's drugs.

What happened?

Shares of Aurinia Pharmaceuticals (AUPH -4.04%) are up by 10.4% as of 11:15 a.m. EDT on Wednesday, after the company announced that the U.S. Food and Drug Administration (FDA) accepted the filing of a New Drug Application (NDA) for Voclosporin. 

So what

Voclosporin is a potential treatment for Lupus Nephritis, an inflammation of the kidneys that can lead to kidney failure. Lupus Nephritis is caused by systemic lupus erythematosus (SLE), which is an autoimmune disorder. Aurinia initially submitted its NDA for Voclosporin in late May. The FDA granted Voclosporin priority review, which reduces the process to six months, as opposed to the standard of 10 months. The health-industry regulator has assigned a target-action date of Jan. 22, 2021.

Peter Greenleaf, CEO of Aurinia, said:

People living with [Lupus Nephritis] are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage. 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.

Five upward pointing arrows on a blackboard.

Image source: Getty Images.

Now what

SLE affects about 445,000 people in the U.S., up to 50% of whom develop Lupus Nephritis. What's more, there are currently no FDA-approved treatments for this disease.

In other words, there's a dire need for Aurinia's Voclosporin, and if approved, this therapy could become a key growth driver for the company. No wonder, then, that investors are bidding up shares of the biotech following the FDA's acceptance of its NDA for Voclosporin. 

Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Aurinia Pharmaceuticals Inc. Stock Quote
Aurinia Pharmaceuticals Inc.
$7.49 (-4.04%) $0.32

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/29/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.