Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) is soaring in the market this morning, trading on gains of more than 80% after announcing data. The data came from a pivotal trial, suggesting that a New Drug Application is coming soon. Here’s what’s going on:
AUPH Stock Heads Up On Pivotal Data
In a press release issued early this morning, Aurinia Pharmaceuticals announced positive data from its pivotal AURORA clinical trial. AURORA is a Phase 3 trial assessing voclosporin in combination with mycophenolate and low-dose corticosteroids for the treatment of lupus nephritis.
In the study, 357 patients with active LN were provided with treatment. AUPH said that the study met its primary endpoint of positive Renal Response rates. In fact, in the voclosporin arm, response rates came in at 40.8% compared to the control arm with response rates at 22.5%.
Moreover, the company said that all pre-specified secondary endpoints were achieved. These included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatine ratio and time to 50% reduction in UPCR.
Importantly, AUPH said that the treatment was well tolerated with no unexpected safety signals. While serious adverse events were reported in 20.8% of the voclosporin arm, serious adverse events were reported in 21.3% of the control arm.
The most commonly reported serious adverse event proved to be infection. Moreover, mortality was low overall. One death took place in the voclosporin arm with five deaths taking place in the control arm.
In a statement, Neil Solomons, M.D., CMO at Aurinia Pharmaceuticals, had the following to offer:
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. This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death.
The above statement was followed up by Peter Greenleaf, President and CEO at AUPH. Here’s what he had to offer:
We are thrilled with the outcomes reported today from the AURORA trial, which unequivocally demonstrate the tremendous potential for voclosporin to play an important role in the treatment of the approximately one million people worldwide living with LN
We are aware of the intense need for a clinically impactful therapy for this serious disease and are working with urgency to complete regulatory filings in the U.S. and worldwide. If approved, we look forward to potentially making voclosporin available to patients beginning in 2021.
Why Investors Are Sending The Stock Soaring
Sure, data was released, but data is often released. What doesn’t happen often is seeing a stock nearly double as a result. So, why are investors so excited. Well, there are a few very good reasons:
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First and foremost, positive results came from a pivotal Phase 3 clinical trial. These trials tend to be the last studies before a New Drug Application is submitted to the Food and Drug Administration. So, with the positive results in mind, chances are that a regulatory submission is around the corner. That’s exciting for any biotech investor.
However, the excitement goes a bit further. If the results reported are accurate, this is some of the best data that we’ve seen in any treatment designed to target Lupus Nephritis. So, should the product hit the market, it will likely do very well in commercial stages.
This is important as it is expected that over the next few years, the Lupus Nephritis treatment market will grow to be worth $2.7 billion annually. While AUPH isn’t likely to take 100% of this market, with a drug that is showing better results than anything else out there, there’s a good chance that the company can take the lion’s share.
All in all, there are several good reasons to be excited here and they all point to the potential for significant revenue growth ahead.
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