Business
ChemoCentryx Reports Third Quarter 2020 Financial Results and Recent Highlights
-- New Drug Application (NDA) accepted for review by U.S. Food and Drug Administration (FDA) for avacopan in ANCA-associated vasculitis with PDUFA goal date
About this update from Chemocentryx Inc.
[{"type":"text","content":"-- New Drug Application (NDA) accepted for review by U.S. Food and Drug Administration (FDA) for avacopan in ANCA-associated vasculitis with PDUFA goal date of July 7, 2021 --\n -- Marketing Authorization Application (MAA) validated by the European Medicines Agency (EMA) for avacopan in ANCA-associated vasculitis -- -- Topline data from AURORA Phase II clinical trial of avacopan in Hidradenitis Suppurativa (HS) leads to Company plans for Phase III trial of avacopan in patients with most severe form of HS -- -- Topline Data from ACCOLADE trial expected YE 2020 for avacopan for C3 Glomerulopathy (C3G) -- -- Novel orally administered checkpoint inhibitor CCX559 to enter clinical development for next generation cancer treatment in H1 2021; avacopan study initiation for Lupus Nephritis on track in same time frame -- -- Conference call today at 5:00 p.m. Eastern Time -- MOUNTAIN VIEW, Calif., Nov. 09, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced financial results for the third quarter ended September 30, 2020 and provided an overview of the Company's recent corporate highlights. \"A powerful current of progress propels our enterprise, as exemplified by the recent FDA acceptance for review of our NDA for avacopan for the treatment of ANCA-associated vasculitis,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We ready ourselves for the bright prospect of changing the treatment paradigm in ANCA vasculitis, while also pursuing the rest of our avacopan pipeline-in-a-drug strategy. To that end, we expect to announce topline data from avacopan in C3G by the end of this year, and we are also on track to start clinical development of avacopan in lupus nephritis and initiate a pivotal Phase III trial of avacopan in patients with severe hidradenitis suppurativa in 2021. Beyond that -- let’s not forget -- our orally-administered small molecule checkpoint inhibitor CCX559, designed to be a next generation cancer treatment, is also slated to enter the clinic in the first half of 2021.” Dr. Schall continued, “The marked progress that we have generated in recent quarters at ChemoCentryx continues to drive us toward our goal of becoming a fully-integrated company that provides new kinds of therapies for the most critical diseases. History shows that our unique discovery and develop...