ChemoCentryx (CCXI) Tavneos Gets FDA Nod for ANCA Vasculitis
ChemoCentryx CCXI 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).
The drug will be marketed under the brand name Tavneos. 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.
We inform investors that Tavneos is the company’s first drug to receive FDA approval.
Shares of the company skyrocketed in pre-market trading on Oct 8 following the news. Yet, the company’s stock has plunged 68.4% so far this year in comparison with the industry’s 17.6% decline.
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The approval of the drug is based on data from the phase III ADVOCATE study, which evaluated the drug in the given indication. 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.
ANCA-associated vasculitis is caused by over-activation of the complement system that further activates neutrophils. This results in inflammation and destruction of small blood vessels.
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.
We remind investors that the drug has received approval for a similar indication in Japan. The company has also filed regulatory applications for the drug in the EU for the given indication, with an expected review by 2021-end.
Apart from ANCA vasculitis, the company is evaluating avacopan as a potential treatment for C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN). Both the FDA and EMA have granted Orphan drug designation to Tavneos for C3G indication.
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 Horizon Therapeutics HZNP, Regeneron Pharmaceuticals REGN and Vertex Pharmaceuticals VRTX. While both Horizon and Vertex sport a Zacks Rank #1 (Strong Buy), Regeneron holds a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $4.46 to $4.62 in the past 60 days. The same for 2022 has risen from $5.84 to $6.12 over the same period. The stock has rallied 55.4% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $52.83 to $61.41 in the past 60 days. The same for 2022 has risen from $44.12 to $46.73 over the same period. The stock has rallied 14.3% in the year so far.
Vertex’s earnings per share estimates for 2021 have increased from $12.28 to $12.37 in the past 60 days. The same for 2022 has risen from $13.02 to $13.13 over the same period.
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