BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
07/09/2021
Initial Lawsuit
07/09/2021
Lawsuit Progression
09/13/2021
Investigation regarding Orphazyme’s statements in connection with its initial public offering (IPO) about its lead candidate arimoclomol for the treatment of Niemann-Pick disease type C (NPC), Amyotrophic Lateral Sclerosis (ALS), and Inclusion Body Myositis (IBM).
06/18/2021
Orphazyme A/S announces it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C (NPC).
“The FDA issued the CRL based on needing additional qualitative and quantitative evidence to further substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale (NPCCSS) and, in particular, the swallow domain. Further, the FDA noted in the CRL that additional data are needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA.“
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$7.33 | $14.56 | $-7.23 | -49.66% |
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: (a) Orphazyme American depositary shares pursuant and/or traceable to the Offering Documents (defined below) issued in connection with the Company’s initial public offering conducted on or about September 29, 2020; and/or (b) Orphazyme securities between September 29, 2020 and June 18, 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) arimoclomol was not as effective in treating IBM as Defendants had represented;
(ii) arimoclomol was not as effective in treating ALS as Defendants had represented;
(iii) the arimoclomol NDA for NPC was incomplete and/or required additional evidence and data to support the benefit-risk assessment of that NDA;
(iv) as a result of (iii), the FDA was unlikely to approve the arimoclomol NDA for NPC in its present form;
(v) the Company’s overall business prospects, as well as arimoclomol’s commercial prospects, were significantly overstated;
(vi) as a result, the Offering Documents and Defendants’ public statements throughout the Class Period were materially false and/or misleading and failed to state information required to be stated therein.
09/13/2021
The court issued an order appointing the lead plaintiff and lead counsel.
11/19/2021
This is a class action on behalf of all persons or entities, who: (1) purchased or otherwise acquired Orphazyme’s American depository shares (ADS) pursuant and/or traceable to Orphazyme’s registration statement issued in connection with its September 29, 2020 initial public offering (IPO) [...]; and/or (2) purchased or otherwise acquired Orphazyme’s ADS between September 29, 2020 and November 4, 2021, both dates inclusive [...].
Operative complaint
01/21/2022
A motion to dismiss was filed with the court.
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.