Investigation
03/01/2021
Initial Lawsuit
03/01/2021
Lawsuit Progression
05/06/2021
Investigation regarding Aquestive’s statement about its new drug application (NDA) for Libervant (lower weight groups’ drug exposure in a study submitted).
09/28/2020
Aquestive announces the receipt of a Complete Response Letter (CRL) from the FDA regarding its NDA for Libervant. The company explains that the NDA cannot be approved in its current form because “in a study submitted by the Company with the NDA, certain weight groups showed a lower drug exposure level than desired.“
See more on Factual TimelinePlaintiff brings this securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Aquestive securities between December 2, 2019 and September 25, 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 included in the Libervant NDA submission showed a lower drug exposure level than desired for certain weight groups;
(ii) the foregoing significantly decreased the Libervant NDA’s approval prospects;
(iii) as a result, it was foreseeable that the FDA would not approve the Libervant NDA in its current form; and
(iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
05/06/2021
The court issued an order appointing the lead plaintiff and lead counsel.
06/25/2021
Lead plaintiff brings this securities class action brought on behalf of all persons who purchased Aquestive common stock between August 7, 2019 and September 25, 2020, both dates inclusive.
Operative complaint
08/16/2021
A motion to dismiss was filed with the court.