Quote Zacks Rank & Stocks to ConsiderĬhemoCentryx currently carries a Zacks Rank #3 (Hold). Both the FDA and EMA have granted Orphan drug designation to Tavneos for C3G indication.ĬhemoCentryx, Inc.
The company has also filed regulatory applications for the drug in the EU for the given indication, with an expected review by 2021-end.Īpart from ANCA vasculitis, the company is evaluating avacopan as a potential treatment for C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN). We remind investors that the drug has 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. This results in inflammation and destruction of small blood vessels.
Data from the study demonstrated that treatment with the drug achieved disease remission at 26 weeks, with sustained remission at 52 weeks as measured by the Birmingham Vasculitis Activity Score - the primary endpoint of the study.ĪNCA-associated vasculitis is caused by over-activation of the complement system that further activates neutrophils. The approval of the drug is based on data from the phase III ADVOCATE study, which evaluated the drug in the given indication. Yet, the company’s stock has plunged 68.4% so far this year in comparison with the industry’s 17.6% decline. Shares of the company skyrocketed in pre-market trading on Oct 8 following the news. We inform investors that Tavneos is the company’s first drug to receive FDA approval. The drug has received approval from the FDA as an adjunctive treatment combined with standard therapy for two main forms of ANCA-associated vasculitis - granulomatosis with polyangiitis and microscopic polyangiitis. The drug will be marketed under the brand name Tavneos. ChemoCentryx ( CCXI Quick Quote CCXI - Free Report) announced that the FDA has approved its lead candidate, avacopan, for the treatment of adult patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
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