ChemoCentryx (CCXI) Stock Rockets On FDA Approval

ChemoCentryx Inc (NASDAQ: CCXI) is screaming for the top in the market this morning, and for good reason. The company announced that it has received approval from the United States Food and Drug Administration for TAVNEOS. Here’s the scoop:

Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!

CCXI Stock Gains On TAVNEOS Approval

In the press release, ChemoCentryx said that the FDA has approved TAVNEOS. TAVNEOS is an orally administered selective complement 5a receptor inhibitor that was designed for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. 

ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils. This leads to inflammation and eventual destruction of small blood vessels. Ultimately, this damage results in organ damage and failure, with the kidney as the major target. Unfortunately, the condition is often fatal if not treated. 

Management Commentary

In a statement, Thomas J. Schall, Ph.D., President and CEO at CCXI, had the following to offer:

Today is a momentous day in the history of ChemoCentryx; the culmination of decades of effort aimed at offering new hope to patients with this and other debilitating and deadly diseases. We look forward to making TAVNEOS available to clinicians and patients in the next few weeks. We thank the Agency for their collaboration and consideration and we are also immensely grateful to the pioneering scientists, clinicians and patients who believed in the promise of TAVNEOS and who have worked tirelessly to make it a reality, along with my dedicated and talented colleagues at ChemoCentryx.

The above statement was followed up by Peter A. Merkel, MD, MPH, Chief of Rheumatology at the Perelman School of Medicine at the University of Pennsylvania, Director of the international Vasculitis Clinical Research Consortium, consultant to ChemoCentryx and co-primary investigator on the trial. Here’s what he had to offer:

I am excited that our work has helped lead to the first-in-a-decade approval of a medicine for ANCA-associated vasculitis. This is an important step forward in the treatment of this disease. Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vasculitis.

Finally, Joyce Kullman, Executive Director of the Vasculitis Foundation, said:

The vasculitis community is elated that TAVNEOS is now approved, bringing a much-needed new treatment option to patients living with this devastating disease. There is a significant unmet need in the treatment of ANCA-associated vasculitis, with current therapies often leading to serious, even fatal, side effects and a diminished quality of life. We believe new therapies like TAVNEOS may offer a brighter future for these patients.

Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!

The Bottom Line

The bottom line here is simple. With this new approval, the company now has the ability to market a treatment, generating revenue and potential profits for its investors. All in all, today’s a great day for CCXI and its investors. 

Don't Miss the Next Big Story

Join our free mailing list below to receive real-time, actionable alerts!