ChemoCentryx, Inc. (CCXI) Misled Investors Regarding the Company’s Concerns for User Safety
On November 25, 2019, ChemoCentryx, Inc. (CCXI) announced “Positive Topline Data from Pivotal Phase III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA-Associated Vasculitis.” The announcement stated that the ADVOCATE Phase III Trial “met both of its primary endpoints,” and that “[t]he topline safety results revealed an acceptable safety profile in this serious and life-threatening disease.” Further, the Company’s President, CEO, and Chairman of the Board of Directors, stated that these results exceeded the Company’s expectations and “demonstrated that a highly targeted therapy aimed at the very center of the ANCA disease process is superior to the tradition approach…” On this news, ChemoCentryx shares soared from their November 25, 2019 close of $8.06 per share to a November 26, 2019 opening price of $34.82.
For the next several months, defendants repeatedly touted the results of the ADVOCATE Phase III trial and the efficacy of avacopan for the treatment of ANCA-associated vasculitis. In July 2020, ChemoCentryx announced that it had file its New Drug Application (“NDA”) for avacopan and in September 2020, it announced that the U.S. Food and Drug Administration (“FDA”) had accepted the NDA for review.
Then, on May 4, 2021, the FDA published a Briefing Document concerning avacopan’s NDA, which noted “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 further stated, “the review team has identified several areas of concern, raising uncertainties about the interpretability of these data and the clinical meaningfulness of these results…” On this news, shares of ChemoCentryx plummeted over 45% to close at $26.63 per share on May 4, 2021.
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