BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
12/20/2020
Initial Lawsuit
12/20/2021
Lawsuit Progression
04/22/2022
Investigation following the FDA’s Advisor Committee’s negative vote on the question of whether Reata’s provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks.
12/08/2021
The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee meeting on bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome takes place. The committee votes no on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks.
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$29.11 | $54.42 | $-25.31 | -46.51% |
Plaintiff brings this securities class action on behalf of persons and entities that purchased or otherwise acquired Reata securities, and/or sold Reata put options, between November 9, 2020 and December 8, 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:
(1) that the FDA had raised concerns regarding the validity of the clinical study designed to measure the efficacy and safety of bardoxolone for the treatment of chronic kidney disease caused by Alport syndrome;
(2) that, as a result, there was a material risk that Reata’s NDA would not be approved; and
(3) that, as a result of the foregoing, defendants’ positive statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
04/22/2022
The court issued an order appointing the lead plaintiff and lead counsel.
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.