Benzinga | Jul 6, 2021 09:18AM EDT

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

* Following consultations with the FDA, ChemoCentryx Inc (NASDAQ:CCXI) filed 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.