ChemoCentryx, Inc.

ChemoCentryx is a biopharmaceutical company. Its lead drug candidate is avacopan, which is developed as a potential treatment for ANCA-associated vasculitis (“AAV”).  

On July 9, 2020, ChemoCentryx announced that it had filed its New Drug Application (“NDA”) for avacopan to the U.S. Food and Drug Administration (“FDA”) for the treatment of AAV.

On May 4, 2021, the FDA released a Briefing Document concerning the Company’s NDA for avacopan, stating 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 also noted that “several areas of concern [that] rais[ed] 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 AAV.

On this news, the Company’s stock price fell $22.19 per share, or 45.45%, to close at $26.63 per share on May 4, 2021, thereby injuring investors.  

Then, on May 6, 2021, after the market closed, ChemoCentryx announced that the FDA Advisory Committee was evenly divided as to whether the efficacy data supported approval of avacopan. Multiple analysts commented on the news. For example, J.P. Morgan noted that “while the vote was more 50/50-ish, we note that commentary by the panel was skewed to more of a negative tone.”

On this news, the Company’s stock price fell $17.03 per share, or 62%, to close at $10.46 per share on May 7, 2021, thereby injuring investors further.

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants 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, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.