BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
12/07/2020
Initial Lawsuit
01/06/2021
Lawsuit Progression
04/02/2021
Investigation regarding statements made by Tricida about its drug candidate veverimer (TRC101) designed to treat metabolic acidosis in patients with chronic kidney disease. Notably, communication with the FDA regarding its New Drug Application (NDA) and the potential need for additional data beyond the TRCA-301 and TRCA-301E trials.
10/29/2020
Tricida announces an update on the Type A meeting with the FDA following the CRL. Tricida proposed to conduct an interim analysis of serum bicaronate data from its ongoing VALOR-CKD (TRCA-303) in approximately 500 patients for purposes of confirming the treatment effect of veverimer observed in previous trials. But the FDA was believed to “require evidence of veverimer’s effect on CKD progression from a near-term interim analysis of the VALOR-CKD trial” for approval of the NDA; Tricida disclosed it would not be able to provide such information without compromising the integrity of the ongoing trial.
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$4.37 | $8.27 | $-3.9 | -47.16% |
Plaintiff brings this securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Tricida securities between September 4, 2019 and October 28, 2020, both dates 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:
(i) Tricida’s NDA for veverimer was materially deficient;
(ii) accordingly, it was foreseeably likely that the FDA would not accept the NDA for veverimer;
(iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.
04/02/2021
The court issued an order appointing the lead plaintiff and lead counsel.
06/01/2021
This action is brought on behalf of all investors who purchased Tricida common stock during the period June 28, 2018 through February 25, 2021.
Operative complaint
07/16/2021
A motion to dismiss was filed with the court.
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