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ChemoCentryx (CCXI) Tavneos Gets EU Nod for ANCA Vasculitis
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ChemoCentryx announced that it has received approval in the European Union (EU) for its drug, Tavneos (avacopan), to treat adult patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
Tavenos has received approval in the EU as an adjunctive treatment combined with rituximab or cyclophosphamide for two main forms of ANCA-associated vasculitis — granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The EU approval is also applicable in Iceland, Liechtenstein and Norway.
The approval was expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending Tavneos in the given indication in November.
ChemoCentryx expects to launch Tavneos in the first half of 2022.
Shares of ChemoCentryx have plunged 53.4% so far this year in comparison with the industry’s 30.8% decline.
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We note that the EU is the third market in which ChemoCentryx has received approval for Tavneos in ANCA-associated vasculitis indication. Last October, the share price of ChemoCentryx surged after it announced that Tavneos received approval from the FDA as an adjunctive treatment combined with standard therapy for two main forms of ANCA-associated vasculitis - GPA and MPA. Tavneos has also received approval for a similar indication in Japan.
ChemoCentryx has partnered with Vifor Pharmaceuticals to commercialize Tavneos outside the United States. The company earns royalties up to mid-20s percent on Tavneos’ sales from Vifor. Approval in additional geographies will boost the drug’s prospects.
ANCA vasculitis is an orphan, severe and often fatal autoimmune disease characterized by the inflammation of blood vessels caused when the immune system mistakenly attacks them, commonly affecting kidneys.
Per ChemoCentryx, Tavneos will provide a new and safer mode of treatment to patients with ANCA-associated vasculitis over the current mode of treatments.
Apart from ANCA vasculitis, ChemoCentryx is evaluating avacopan as a potential treatment for C3 glomerulopathy, hidradenitis suppurativa and Lupus Nephritis.
Alkermes’ earnings per share estimates for 2022 have increased from $0.70 to $0.71 in the past 60 days. Shares of Alkermes have risen 12.2% in the past year.
Earnings of Alkermes beat estimates in all the last four quarters, delivering a surprise of 147%, on average.
BioNTech’s earnings per share estimates for 2022 have increased from $31.14 to $32.72 in the past 60 days. Shares of BioNTech have risen 56.6% in the past year.
Earnings of BioNTech beat estimates in all the last four quarters, delivering a surprise of 132.4%, on average.
Vir Biotechnology’s bottom-line estimates for 2022 have been revised from a loss of $0.47 per share to earnings of $6.82 in the past 60 days.
Earnings of Vir Biotechnology beat estimates in two of the last four quarters while missing on the other two occasions, with an average surprise of 13%.
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ChemoCentryx (CCXI) Tavneos Gets EU Nod for ANCA Vasculitis
ChemoCentryx announced that it has received approval in the European Union (EU) for its drug, Tavneos (avacopan), to treat adult patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
Tavenos has received approval in the EU as an adjunctive treatment combined with rituximab or cyclophosphamide for two main forms of ANCA-associated vasculitis — granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The EU approval is also applicable in Iceland, Liechtenstein and Norway.
The approval was expected as the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending Tavneos in the given indication in November.
ChemoCentryx expects to launch Tavneos in the first half of 2022.
Shares of ChemoCentryx have plunged 53.4% so far this year in comparison with the industry’s 30.8% decline.
We note that the EU is the third market in which ChemoCentryx has received approval for Tavneos in ANCA-associated vasculitis indication. Last October, the share price of ChemoCentryx surged after it announced that Tavneos received approval from the FDA as an adjunctive treatment combined with standard therapy for two main forms of ANCA-associated vasculitis - GPA and MPA. Tavneos has also received approval for a similar indication in Japan.
ChemoCentryx has partnered with Vifor Pharmaceuticals to commercialize Tavneos outside the United States. The company earns royalties up to mid-20s percent on Tavneos’ sales from Vifor. Approval in additional geographies will boost the drug’s prospects.
ANCA vasculitis is an orphan, severe and often fatal autoimmune disease characterized by the inflammation of blood vessels caused when the immune system mistakenly attacks them, commonly affecting kidneys.
Per ChemoCentryx, Tavneos will provide a new and safer mode of treatment to patients with ANCA-associated vasculitis over the current mode of treatments.
Apart from ANCA vasculitis, ChemoCentryx is evaluating avacopan as a potential treatment for C3 glomerulopathy, hidradenitis suppurativa and Lupus Nephritis.
ChemoCentryx, Inc. Price
ChemoCentryx, Inc. price | ChemoCentryx, Inc. Quote
Zacks Rank & Other Stocks to Consider
ChemoCentryx currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the same sector include Alkermes (ALKS - Free Report) , BioNTech (BNTX - Free Report) and Vir Biotechnology (VIR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates for 2022 have increased from $0.70 to $0.71 in the past 60 days. Shares of Alkermes have risen 12.2% in the past year.
Earnings of Alkermes beat estimates in all the last four quarters, delivering a surprise of 147%, on average.
BioNTech’s earnings per share estimates for 2022 have increased from $31.14 to $32.72 in the past 60 days. Shares of BioNTech have risen 56.6% in the past year.
Earnings of BioNTech beat estimates in all the last four quarters, delivering a surprise of 132.4%, on average.
Vir Biotechnology’s bottom-line estimates for 2022 have been revised from a loss of $0.47 per share to earnings of $6.82 in the past 60 days.
Earnings of Vir Biotechnology beat estimates in two of the last four quarters while missing on the other two occasions, with an average surprise of 13%.