May 3, 2021 - An investor in shares of ChemoCentryx, Inc. (NASDAQ: CCXI) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by ChemoCentryx, Inc. in connection with certain allegedly false and misleading statements made between November 26, 2019 and May 3, 2021.
Mountain View, CA based ChemoCentryx, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of new medications for inflammatory disorders, autoimmune diseases, and cancer in the United States. ChemoCentryx, Inc. reported that its annual Total Revenue rose from $35.95 million in 2019 to $64.39 million in 2020.
On May 4, 2021, the U.S. Food and Drug Administration released a "Briefing Document" concerning ChemoCentryx's drug candidate avacopan, which is in development for the treatment of adult patients with anti-neutrophil cytoplasmic autoantibody vasculitis. In this Briefing Document, the FDA wrote that its review team "has identified several areas of concern, raising uncertainties about the interpretability of the data" submitted as part of ChemoCentryx's application, as well as concerns with "the clinical meaningfulness of these results."
ChemoCentryx, Inc. (NASDAQ: CCXI) declined to as low as $9.55 per share on May 7, 2021.
According to the complaint the plaintiff alleges on behalf of purchasers of ChemoCentryx, Inc. (NASDAQ: CCXI) common shares between November 26, 2019 and May 3, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between November 26, 2019 and May 3, 2021, the defendants made false and/or misleading statements and/or failed to disclose that the study design of the Phase III ADVOCATE trial presented issues about the interpretability of the trial data to define a clinically meaningful benefit of avacopan and its role in the management of ANCA-associated vasculitis, that the data from the Phase III ADVOCATE trial raised serious safety concerns for avacopan, that these issues presented a substantial concern regarding the viability of ChemoCentryx's NDA for avacopan for the treatment of ANCA-associated vasculitis, and that as a result of the foregoing, Defendants' public statements were materially false and misleading at all relevant times.