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ChemoCentryx Stock Jumps On Amendment In Avacopan Application, New Goal Date Of October 7

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ChemoCentryx Stock Jumps On Amendment In Avacopan Application, New Goal Date Of October 7
  • Following consultations with the FDA, ChemoCentryx Inc (NASDAQ: CCXIfiled an amendment to its marketing application seeking approval for avacopan to treat Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis addressing concerns raised during the FDA Advisory Committee meeting in May.
  • The FDA has indicated that the filing constitutes a significant amendment to the NDA and will result in the setting of a new PDUFA goal date of October 7. 
  • The application is primarily based on data from the Phase 3 ADVOCATE trial of avacopan.
  • In May, the FDA's Arthritis Advisory Committee voted 9-9 on whether the efficacy data support avacopan approval, 10-8 that the safety profile of avacopan is adequate, and 10-8 that the benefit-risk profile is sufficient.
  • ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. 
  • Price Action: CCXI shares are up 8.9% at $14.35 during the premarket session on the last check Tuesday.
 

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Posted-In: Briefs VasculitisBiotech News Health Care Small Cap FDA General

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