BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
07/22/2021
Initial Lawsuit
07/22/2021
Lawsuit Progression
10/13/2021
Investigation regarding CorMedix’s statements made in connection with its new drug application (NDA) for DefenCath and manufacturing process deficiencies.
03/01/2021
CorMedix announces that the U.S. Food and Drug Administration (FDA) cannot approve the new drug application (NDA) for DefenCath in its present form because of “concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility.” CorMedix added that “satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns.“
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$9.02 | $15 | $-5.98 | -39.87% |
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 CorMedix securities between July 8, 2020 and May 13, 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) deficiencies existed with respect to DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath;
(ii) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for CRBSIs in its present form;
(iii) Defendants had downplayed the true scope of the deficiencies with DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath;
(iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
10/13/2021
The court issued an order appointing the lead plaintiff and lead counsel.
12/14/2021
This is a federal securities class action brought on behalf of two proposed classes: a) All persons who purchased CorMedix securities pursuant or traceable to the company’s November 27, 2020 “At the Market” offering pursuant to CorMedix’s Form S-3 Registration Statement and its Prospectus Supplement, dated November 27, 2020 . . .; and b) All persons and entities, other than defendants, that purchased or otherwise acquired CorMedix securities between October 16, 2019 and September 6, 2021, inclusive. . . .
Operative complaint
02/21/2022
A motion to dismiss was filed with the court.
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.