Stifel Upgrades ChemoCentryx (CCXI) to Buy on Amendment To Avacopan NDA
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ChemoCentryx Announces Filing of Amendment to NDA Submission and Extension of the PDUFA Review Period for Avacopan in the Treatment of ANCA-Associated Vasculitis
July 6, 2021 8:30 AM EDTSAN CARLOS, Calif., July 06, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that, following consultations with the U.S. Food and Drug Administration (FDA), it filed an amendment to its New Drug Application (NDA) for avacopan for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, addressing points raised during the FDA Advisory Committee meeting on May 6, 2021. The FDA has indicated that the filing constitutes a major amendment to the NDA and will result in the setting of a new PDUFA goal date of October 7, 2021. The NDA is... More