
BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
05/05/2021
Initial Lawsuit
05/05/2021
Lawsuit Progression
01/28/2022
Investigation regarding ChemoCentryx’s statements about the design of the Phase III ADVOCATE trial of avacopan, its clinically meaningful benefit and FDA safety concerns.
05/04/2021
The United States Food and Drug Administration (FDA) publishes a Briefing Document concerning ChemoCentryx’s NDA #214487 for avacopan expressing concerns about the phase III ADVOCATE trial meaningfulness: “[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 Advisory Committee also mentionned that it had “identified several areas of concern, raising uncertainties about the interpretability of these data and the clinical meaningfulness of these results . . . ”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$26.63 | $48.82 | $-22.19 | -45.45% |
This is a federal securities class action on behalf of all investors who purchased or otherwise acquired ChemoCentryx, Inc. common stock between November 26, 2019 and May 3, 2021, inclusive.
According to the complaint, 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 allegedly 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;
(4) as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant times.
01/28/2022
The court issued an order appointing the lead plaintiff and lead counsel.
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