BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
11/17/2021
Initial Lawsuit
11/17/2021
Lawsuit Progression
01/18/2022
This investigation follows Owlet’s receipt of a warning letter from the FDA requiring premarket clearance or approval for its Smark Sock device.
10/04/2021
Owlet discloses the receipt of a warning letter from the U.S. Food and Drugs Administration (FDA) asserting that “the company’s marketing of its Owlet Smart Sock product in the United States renders the Smart Sock a medical device requiring premarket clearance or approval from FDA” but the company “has not obtained such clearance or approval” and is “in violation of the Federal, Food, Drug, and Cosmetic Act.”
“Among other things, the Warning Letter requests the Company cease commercial distribution of the Smart Sock for uses in measuring blood oxygen saturation and pulse rate where such metrics are intended to identify or diagnose desaturation and bradycardia using an alarm functionality to notify users that measurements are outside of preset values.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$4.19 | $5.48 | $-1.29 | -23.54% |
This is a class action on behalf of persons and entities:
(a) that purchased or otherwise acquired Owlet securities between March 31, 2021 and October 4, 2021, inclusive; and/or
(b) held Sandbridge common stock held as of June 1, 2021 and were eligible to vote at Sandbridge’s special meeting on July 14, 2021.
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 Owlet was reasonably likely to be required to obtain marketing authorization for the Smart Sock because the FDA concluded it was a medical device;
(2) that, as a result, Owlet was reasonably likely to cease commercial distribution of the Smart Sock in the U.S. until it obtained the requisite approval; 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.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/20/2022.
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.