Close

Stifel Upgrades ChemoCentryx (CCXI) to Buy on Amendment To Avacopan NDA

Go back to Stifel Upgrades ChemoCentryx (CCXI) to Buy on Amendment To Avacopan NDA

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 EDT

SAN 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