CCXI stock rose 5% in early trading on January 19, 2022, after the company announced that the EU approved Tavneos.
ChemoCentryx Announces EU Approval of TAVNEOS® (avacopan) for the Treatment of ANCA-Associated Vasculitis
On January 19, 2022, ChemoCentryx, Inc., (Nasdaq: CCXI), announced that TAVNEOS® (avacopan) has been approved within the European Union in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. This approval follows the U.S. Food and Drug Administration (FDA) approval of TAVNEOS in October 2021. TAVNEOS will receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
“European Union approval of TAVNEOS represents the third major global sector to recognize the value of this long-awaited new treatment for the debilitating and often deadly disease of ANCA-associated vasculitis,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We congratulate our alliance partner, Vifor Pharma, for this significant achievement as we welcome the opportunity for our alliance to serve ANCA patients.”
“This is a significant step forward for patients in Europe living with this systemic condition,” said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge. “They will now have available a new class of medication that meets major unmet medical needs in the treatment of ANCA-associated vasculitis.”
As part of their Kidney Health Alliance, ChemoCentryx retains all rights for TAVNEOS (avacopan) for orphan and renal diseases in the United States and Vifor Pharma has rights to commercialize avacopan in the rest of the world. Vifor will pay ChemoCentryx royalties in the teens to the mid-20s percent on potential ex-U.S. salesThe income statement provides a summary of a company's revenue and expenses over a specified period of time, typically a year or a quarter. It shows the company's total revenue, th... of one aggregate net sales line.
TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN). The U.S. Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for C3G. TAVNEOS has not been approved for indications discussed as in development, and the safety and efficacy of those uses has not been established.
TAVNEOS (avacopan) is indicated in the United States as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
📺 CCXI (ChemoCentryx Inc) Stock Technical Analysis | 1/18/2022[embedyt] https://www.youtube.com/watch?v=z2bC9rBe4zI[/embedyt]
📉 CCXI Stock Technical Analysis
The long-term trend is neutral, but the short-term trend is negative. Better to stay away from this for now. CCXI is part of the Biotechnology industry. There are 633 other stocks in this industry, CCXI did better than 68% of them. CCXI is currently trading in the middle of its 52-week range. The S&P500 Index however is trading in the upper part of its 52-week range, so CCXI is lagging the market slightly. Prices have been falling strongly lately, it is better to avoid new long positions here.
There is a support zone ranging from 30.69 to 30.71. This zone is formed by a combination of multiple trend lines in multiple time frames. There is also support at 20.68 from a trend line in the daily time frame.
There is resistance at 38.73 from a trend line in the daily time frame. There is also resistance at 40.50 from a horizontal line in the daily time frame.
Although the technical rating is bad, CCXI does present a nice setup opportunity. The Setup Rating is 6 out of 10. Prices have been consolidating lately. There is very little resistance above the current price. Click here to sign up for email alerts on CCXI stock and when the Setup Rating is 8 or higher.