ChemoCentryx investors may receive additional information about the case by clicking the link "Submit Your Information" above. If you are a member of the class described above, you may no later than July 6, 2021 move the Court to serve as lead plaintiff of the class, if you so choose.
ChemoCentryx is a biopharmaceutical company focused on the development and commercialization of new medications targeting inflammatory disorders, autoimmune diseases, and cancer. ChemoCentryx’s lead drug candidate is avacopan, which ChemoCentryx describes as a “potential first-in-class, orally-administered molecule that employs a novel, highly targeted mode of action in the treatment of ANCA vasculitis and other complement-driven autoimmune and inflammatory diseases.”
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.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq. (484) 270-1453 or Adrienne Bell, Esq. (484) 270-1435; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.