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ChemoCentryx CCXI announced that it has received a positive recommendation from European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) for its drug, Tavneos (avacopan), for the treatment of adult patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
The CHMP has recommended approval of the drug 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 CHMP recommendation is based on data from a phase III study, which evaluated the safety and efficacy of Tavneos in the given indication for a year. Data from the study demonstrated that participants who were administered the drug showed a higher percentage of sustained remission after 52 weeks compared to the participants in the control group.
A final decision from the European Commission for authorizing the use of Tavneos in GPA and MPA in the European Union is anticipated in January 2022.
Shares of the company were up 2.7% on Nov 12, following the news. Yet, the stock has plunged 36% so far this year in comparison with the industry’s 14.1% decline.
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ChemoCentryx has partnered with Vifor Pharmaceuticals to commercialize Tavneos outside the United States.
Last month, the share price of ChemoCentryx surged after it announced that Tavneos had received approval from the FDA as an adjunctive treatment combined with standard therapy for two main forms of ANCA-associated vasculitis - GPA and MPA. The drug has also received approval for a similar indication in Japan.
Per the company, 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-associated vasculitis, ChemoCentryx is also evaluating the drug as a potential treatment for C3 glomerulopathy, hidradenitis suppurativa and Lupus Nephritis.
ChemoCentryx, Inc. Price
ChemoCentryx, Inc. price | ChemoCentryx, Inc. Quote
Zacks Rank & Stocks to Consider
ChemoCentryx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Catalyst Pharmaceuticals CPRX, Endo International ENDP and Sarepta Therapeutics SRPT. While Endo sports a Zacks Rank #1 (Strong Buy), both Catalyst and Sarepta carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo’s earnings per share estimates for 2021 have increased from $2.29 to $2.84 in the past 30 days. The same for 2022 has risen from $2.24 to $2.47 over the same period.
Endo’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 57.7%.
Catalyst’s earnings per share estimates for 2021 have increased from 39 cents to 41 cents in the past 30 days. The same for 2022 has risen from 56 cents to 58 cents over the same period. The stock has risen 121.9% in the year so far.
Catalyst’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 30.6%.
Sarepta’s loss estimates per share estimates for 2021 have narrowed from $7.06 to $4.99 in the past 30 days. The same for 2022 has narrowed from $4.82 to $3.61 in the past 30 days.
Sarepta’s earnings beat estimates in two of the last four quarters and missed on the other two occasions, delivering an average surprise of 11.1%.
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