BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
09/24/2021
Initial Lawsuit
09/24/2021
Lawsuit Progression
10/26/2021
Investigation regarding Cassava’s statements about the quality and integrity of the scientific data supporting simufilam’s efficacy.
08/24/2021
A citizen petition is submitted to the FDA concerning the accuracy and integrity of clinical data for simufilam. The petition requests that the FDA halts Cassava’s clinical trials pending a thorough audit of the publications and data relied upon by the company:
“[d]etailed analysis of the western blots [relied on by Cassava to support the connection between simufilam and Alzheimer’s] shows a series of anomalies that are suggestive of systematic data manipulation and misrepresentation.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$80.86 | $117.83 | $-36.97 | -31.38% |
Plaintiff brings this securities class action on behalf of persons and entities that purchased or otherwise acquired Cassava securities between September 14, 2020 and August 27, 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 quality and integrity of the scientific data supporting Cassava’s claims for simufilam’s efficacy had been overstated;
(2) data underlying the foundational research for Cassava’s product candidates had been manipulated;
(3) experiments using post-mortem human brain tissue frozen for nearly 10 years was contrary to a basic understanding of neurobiology;
(4) biomarker analysis for patients treated with simufilam had been manipulated to conclude that simufilam was effective;
(5) as a result of the foregoing, there was a reasonable likelihood that Cassava would face regulatory scrutiny in connection with the development of simufilam; and
(6) as a result of all the foregoing, Defendants’ positive statements during the Class Period about the Company’s business metrics and financial prospects and the likelihood of FDA approval were false and misleading and/or lacked a reasonable basis.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/16/2022.
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.