Aurinia Pharmaceuticals Soars Then Plummets: Here’s What Happened
Volatility struck a small-cap pharmaceutical company as shares of Aurinia Pharmaceuticals were trading higher by more than 15 percent early Thursday morning after the company announced an encouraging update. Towards the end of Thursday’s trading the session the company has not only given up all of its gains but it was trading lower by more than six percent on the day.
Aurinia is a clinical-stage bio-pharmaceutical company that develops drugs for the treatment of autoimmune diseases with a focus on lupus nephritis.
The company announced after Wednesday’s market close that it plans on initiating a Phase 3 clinical trial for its treatment of lupus nephritis called voclosporin.
Aurinia further noted that it met with the U.S. Food and Drug Administration (FDA) following the completion of its Phase 2 trial and the new Phase 3 clinical trial’s design will ultimately support a New Drug Application (NDA) submission with the FDA.
The Phase 3 trial will consist of a one-year long double-blind, placebo controlled study of around 320 patients. Patients will be randomized on a 50/50 basis and will either receive 23.7mg of its therapy in conjunction with other treatments or a placebo.
After 24 weeks the company will evaluate how effective its therapy and a successful outcome would be its therapy showing a statistical improvement in various criteria, including normal, stable renal function and improved urinary and protein creatinine ratio.
Aurinia further noted that while its therapy has already received a fast track designation from the FDA, the regulatory body has already informed the company that voclosporin will not be eligible for a breakthrough therapy designation. Nevertheless, the fast track designation implies a closer line of communication between the company and the FDA and the potential for priority review and an option to submit a rolling NDA submission which could speed up the review process.
What Happened To The Stock?
Aurinia’s stock gained more than 15 percent heading into Thursday’s market open. In fact, the stock opened notably higher at $3.25 after closing Thursday’s session at $2.77. The stock quickly sold off on heavy volume and by late morning share were trading below Wednesday’s closing price.
With less than one hour of trading remaining on Thursday, shares were lower by nearly six percent at $2.60 and recently hit an intra-day low of $2.55.
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