BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
02/12/2021
Initial Lawsuit
02/12/2021
Lawsuit Progression
05/04/2021
Dismissal
04/21/2022
The investigation focuses on bluebird’s statements about its application (BLA) for LentiGlobin for sickle cell disease and the delays the company disclosed in 2020.
11/05/2020
bluebird disclosed its financial results for Q3 2020 and announces that it would no longer complete the application (BLA) for LentiGlobin for sickle cell disease for 2021. Instead, bluebird’s executives announced a submission date of late 2022.
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$48.83 | $58.55 | $-9.72 | -16.6% |
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 bluebird securities between May 11, 2020 and November 4, 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) data supporting bluebird’s BLA submission for LentiGlobin for SCD was insufficient to demonstrate drug product comparability;
(ii) Defendants downplayed the foreseeable impact of disruptions related to the COVID-19 pandemic on the Company’s BLA submission schedule for LentiGlobin for SCD, particularly with respect to manufacturing;
(iii) as a result of all the foregoing, it was foreseeable that the Company would not submit the BLA for LentiGlobin for SCD in the second half of 2021; and
(iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
05/04/2021
The court issued an order appointing the lead plaintiff and lead counsel.
07/06/2021
This is a federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased bluebird securities between May 11, 2020 and November 4, 2020, both dates inclusive.
Operative complaint
09/07/2021
A motion to dismiss was filed with the court.
On 04/21/2022, the court dismissed the complaint .
The court “allowed” defendants’ motion to dismiss the complaint.
Plaintiff claims that Defendants intentionally or recklessly disregarded that the comparability plan could not show the comparable potency of LentiGlobin when manufactured using the suspension process because the plan did not involve using SCD patient cells . . .
The amended complaint fails to allege sufficient facts to support the claim that Defendants knew or recklessly did not know that the plan would be rejected by the FDA for this deficiency . . .
Plaintiff fails to allege facts indicating that Defendants intentionally or recklessly disregarded the comparability plan’s deficiency in announcing the accelerated approval timeline . . .
Free File
Order on Motion to Dismiss
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.