NEW YORK, NY / ACCESSWIRE / June 8, 2021 / Bleichmar Fonti & Auld LLP ("BFA") announces that it has filed a class action lawsuit for violations of the federal securities laws against ChemoCentryx, Inc.(NASDAQ:CCXI) ("ChemoCentryx" or the "Company") and the Company's Chief Executive Officer (collectively, "Defendants").
BFA filed this action on behalf of its client, Southeastern Pennsylvania Transportation Authority, in the U.S. District Court for the Northern District of California. The case is captioned Southeastern Pennsylvania Transportation Authority v. ChemoCentryx, Inc., No. 3:21-cv-04357 (N.D. Cal.) and is brought on behalf of investors in ChemoCentryx's common stock between November 26, 2019 and May 6, 2021, inclusive (the "Class Period"), which expands the class period that was asserted in the previously filed securities class action pending against ChemoCentryx captioned Homyk v. ChemoCentryx, Inc., No. 4:21-cv-03343 (N.D. Cal.).
The complaint in this case is substantially similar to the complaint filed in Homyk, which is the first-filed securities class action in this matter. Pursuant to the notice published on May 5, 2021 in connection with the filing of Homyk pursuant to the Private Securities Litigation Reform Act of 1995 ("PSLRA"), investors wishing to serve as Lead Plaintiff must file a motion for appointment as Lead Plaintiff by no later than July 6, 2021. The filing of this complaint does not alter that deadline.
The complaint alleges that throughout the Class Period, Defendants made false and misleading statements about the design and results of the company's Phase III clinical trial, known as ADVOCATE, for its leading drug candidate avacopan, a treatment for the serious and often fatal autoimmune disease known as ANCA vasculitis. In July 2020, ChemoCentryx submitted a New Drug Application with the Food and Drug Administration ("FDA") relying largely on the ADVOCATE trial results. During the Class Period, Defendants repeatedly touted ADVOCATE's "excellent trial design," the "superlative" efficacy results, and "favorable safety results."
These statements were materially false and misleading. In truth, the ADVOCATE trial design was fundamentally flawed, which raised questions about the interpretability of the trial results. On May 4, 2021, the FDA released a "Briefing Document" regarding the ADVOCATE trial. In the Briefing Document, the FDA stated, "[c]omplexities of the study design … raise questions about the interpretability of the data to define a clinically meaningful benefit of avacopan and its role in the management" of ANCA vasculitis. The FDA also questioned the safety results of the ADVOCATE trial, stating "[g]iven the small safety database, conclusions are limited," but noted that even in the limited data, it observed serious concerns including "imbalances in hepatoxicity, liver enzyme elevations, and angioedema."
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. These disclosures caused the value of ChemoCentryx stock to decline dramatically, resulting in significant harm to investors.
BFA issues this notice in accordance with the PSLRA and Northern District of California Civil Local Rule 23-1(a).
BFA is a law firm based in New York City with additional offices in Oakland, California; Toronto, Canada; and White Plains, New York. The Firm focuses on securities class actions and other investment-related matters. BFA currently serves as lead counsel in multiple securities class actions and has recovered hundreds of millions of dollars for investors. For more information about BFA, please visit https://www.bfalaw.com/.
Javier Bleichmar, Esq., Peter E. Borkon, Esq.
7 Times Square, 27th Floor, New York, NY 10036, (212) 789-1340, info@bfalaw.com
SOURCE: Bleichmar, Fonti, & Auld LLP
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