NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of investors that purchased ChemoCentryx, Inc. (NASDAQ: CCXI) securities between November 26, 2019 and May 3, 2021, inclusive (the “Class Period”). Investors have until July 6, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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The Class Period commences on November 26, 2019. After the market closed on November 25, 2019, ChemoCentryx issued a press release announcing “Positive Topline Data from Pivotal Phase III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA-Associated Vasculitis.” Throughout the Class Period, the defendants lauded the results of the ADVOCATE Phase III trial, as well as the safety profile of avacopan for the treatment of ANCA-associated vasculitis (“AAV”).
However, the truth was revealed on May 3, 2021 when, the United States Food and Drug Administration (“FDA”) published a Briefing Document concerning ChemoCentryx’s New Drug Application (“NDA”) #214487 for avacopan. In this Briefing Document, the FDA wrote that “[c]omplexities of the study design, as detailed in the briefing document, raise questions about the interpretability of the data to define a clinically meaningful benefit of avacopan and its role in the management of AAV.” The Briefing Document continued that “[a]lthough primary efficacy comparisons were statistically significant, the review team has identified several areas of concern, raising uncertainties about the interpretability of these data and the clinical meaningfulness of these results.” The FDA also raised serious safety concerns with avacopan for the treatment of ANCA-associated vasculitis.
Following this news, the price of ChemoCentryx’s common stock fell over 45% in one day, down from its May 3, 2021 closing price of $48.82 per share to a May 4, 2021 close of $26.63 per share.
The complaint alleges that throughout the Class Period, the defendants misrepresented and/or failed to disclose to investors that: (1) 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; (2) the data from the Phase III ADVOCATE trial raised serious safety concerns for avacopan; (3) these issues presented a substantial concern regarding the viability of ChemoCentryx’s NDA for avacopan for the treatment of ANCA-associated vasculitis; and (4) as a result of the foregoing, the defendants’ public statements were materially false and misleading at all relevant times.
If you purchased ChemoCentryx securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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