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RADNOR, PA / ACCESSWIRE / June 19, 2021 / The law firm of Kessler Topaz Meltzer & Check, LLP reminds investors of ChemoCentryx, Inc. (NASDAQ:CCXI) ("ChemoCentryx") that a securities fraud class action lawsuit has been filed against on behalf of those who purchased or acquired ChemoCentryxcommon stock between November 26, 2019 and May 6, 2021, inclusive (the "Class Period").
Deadline Reminder: Investors who purchased or acquired ChemoCentryx common stockduring the Class Period may, , seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation 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; via e-mail email@example.com; orclick https://www.ktmc.com/chemocentryx-class-action-lawsuit?utm_source=PR&utm_medium=link&utm_campaign=chemocentryx
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 for the treatment of patients with ANCA vasculitis."
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 began to be revealed on May 4, 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 FDA 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." In the Briefing Document, 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.
Then, on May 6, 2021, ChemoCentryx announced that an Advisory Committee of independent experts that the FDA convened to offer their opinions on the ADVOCATE trial was evenly divided as to whether the efficacy data from ADVOCATE supported approval of avacopan. Many members of the Advisory Committee expressed concerns about the robustness of the trial and the insufficient amount of safety data. Some members of the Advisory Committee called on ChemoCentryx to run another Phase III trial. Following this news, ChemoCentryx's common stock price per share dropped from $27.49 per share at the close of trading on May 6, 2021 to $10.46 per share at the close of trading on May 7, 2021.
The complaint alleges that throughout the Class Period, the defendants misrepresented and/or failed to disclose to investors that: (1) ChemoCentryx's design for the ADVOCATE Phase III trial was fundamentally flawed, which raised questions about the interpretability of the trial data and the ability to define a clinically meaningful benefit of avacopan and its role in the treatment of ANCA-associated vasculitis; (2) the results from the ADVOCATE trial raised serious safety concerns for avacopan; and (3) these issues raised significant doubt about the viability of ChemoCentryx's NDA for avacopan for the treatment of ANCA-associated vasculitis. As a result, the defendants' statements about the ADVOCATE trial design, and efficacy and safety results were materially false and misleading at all relevant times.
ChemoCentryx investors may, , seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a 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 affected by the decision of whether or not to serve as a lead plaintiff.
Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
(844) 887-9500 (toll free)
SOURCE: Kessler Topaz Meltzer & Check, LLP