Business
ChemoCentryx Reports Second Quarter 2021 Financial Results and Recent Highlights
-- Company filed an amendment to its NDA for avacopan in the treatment of ANCA-associated vasculitis; PDUFA goal date extended to October 7, 2021-- --
About this update from Chemocentryx Inc.
[{"type":"text","content":"-- Company filed an amendment to its NDA for avacopan in the treatment of ANCA-associated vasculitis; PDUFA goal date extended to October 7, 2021-- -- Applications for regulatory approval of avacopan in ANCA-associated vasculitis also under review by the European Medicines Agency and the Japan Pharmaceuticals and Medical Devices Agency -- -- Clinical development launched of potential next generation checkpoint inhibitor CCX559, featured in abstract at Annual Meeting of American Association for Cancer Research -- -- $402.6 million in cash and investments at June 30, 2021 -- -- Conference call today at 5:00 p.m. Eastern Time -- SAN CARLOS, Calif., Aug. 09, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced financial results for the second quarter ended June 30, 2021 and provided an overview of recent corporate highlights. \"We appreciate the recent opportunity to provide the U.S. FDA with supplementary data and analyses to our NDA, which the Agency deemed to be a major amendment,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We are looking forward to decisions later this year on regulatory submissions for avacopan in ANCA-associated vasculitis in the U.S. and abroad. Meanwhile, we are further developing our pipeline, as evidenced by the launch of a Phase I study with our novel orally-administered immune checkpoint inhibitor CCX559, which we hope will be part of a new era of precise cancer treatment. Further clinical work in other high need areas, such as the initiation of a Phase III trial of avacopan in patients with severe Hidradenitis Suppurativa, constitute important next steps in building the CCXI pipeline to benefit patients most in need.” Key Second Quarter 2021 Highlights and Recent Developments In July the Company announced the filing of additional information to its NDA submission, which the FDA deemed to be a major amendment. The PDUFA review period for avacopan in the treatment of ANCA-associated vasculitis was extended, with a new PDUFA goal date of October 7, 2021. The Company’s filing followed the May 6 meeting of the FDA’s Arthritis Advisory Committee.In Q2, the Company initiated Phase I clinical development of CCX559, a novel, orally-administered, PD-1/PD-L1 checkpoint inhibitor. CCX559 was featured in an abstract at the April 2021 Annual Meeting o...