ChemoCentryx Announces Approval Of TAVNEOS In Japan - Quick Facts

(RTTNews) - ChemoCentryx, Inc. (CCXI) announced the approval of TAVNEOS, an orally administered selective complement 5a receptor inhibitor, in Japan for the treatment of patients with microscopic polyangiitis and granulomatosis with polyangiitis. ChemoCentryx noted that this is the first ever approval by a regulatory agency of a medication discovered and developed by the company. Kissei Pharmaceutical Co. has an exclusive license to commercialize TAVNEOS in Japan.

ChemoCentryx noted that the PDUFA goal date for the FDA decision on the amended NDA is October 7, 2021. The regulatory decision in Europe following the EMA review is expected by the end of 2021.

Shares of ChemoCentryx were up 4% in pre-market trade on Monday.