
BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
11/05/2021
Initial Lawsuit
01/18/2022
Lawsuit Progression
04/06/2022
Investigation in connection with NRx’s statements made in connection with its application filed with the FDA requesting Emergency Use Authorization (EUA) for ZYESAMI (Aviptadil-acetate) to treat critically ill COVID-19 patients suffering with respiratory failure.
11/04/2021
NRx Pharmaceuticals announces that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI (aviptadil). The FDA stated that it was unable to issue the EUA “due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure.” The FDA noted that it had reviewed safety in only 131 randomized patients treated with ZYESAMI.
“NRx will attempt to coordinate a review by the FDA of the 150 or more additional patients already treated with ZYESAMI in the NIH ACTIV-3b trial. Last week, the study’s Data Safety and Monitoring Board reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$6.65 | $8.92 | $-2.27 | -25.45% |
This is a federal securities class action on behalf of a class consisting of all persons and entities other than defendants that purchased or otherwise acquired NRx securities between June 1, 2021 and November 4, 2021, 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) the application with [the] U.S. Food and Drug Administration requesting Emergency Use Authorization (EUA) for ZYESAMI (Aviptadil-acetate) to treat critically ill COVID-19 patients suffering with respiratory failure contained insufficient data regarding the potential benefits and risks of ZYESAMI;
(ii) accordingly, the FDA was unlikely to approve the ZYESAMI EUA application in its present form; and
(iii) as a result, the company’s public statements were materially false and misleading at all relevant times.
04/06/2022
The court issued an order appointing the lead plaintiff and lead counsel.
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