Aquestive Therapeutics, Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired Aquestive Therapeutics, Inc. (“Aquestive Therapeutics” or the “Company”) (NASDAQ: AQST) securities from December 2, 2019 through September 25, 2020, inclusive (the “Class Period”). Investors have until April 30, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
The Company's most advanced proprietary product candidate is Libervant (diazepam), a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures. On December 2, 2019, Aquestive announced the completion of the rolling submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for Libervant Buccal Film for the management of seizure clusters (the "Libervant NDA").
On September 25, 2020, Aquestive announced receipt of a Complete Response Letter ("CRL") from the FDA indicating that the review cycle for the Libervant NDA was complete but the application could not be approved in its current form. Specifically, Aquestive advised investors that "[i]n the CRL, the FDA cited that, in a study submitted by the Company with the NDA, certain weight groups showed a lower drug exposure level than desired. The Company intends to provide to the FDA additional information on PK modeling to demonstrate that dose adjustments will obtain the desired exposure levels." On this news, Aquestive's stock price fell $2.64 per share, or 34.69%, to close at $4.97 per share on September 28, 2020.
If you purchased or otherwise acquired Aquestive Therapeutics securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at firstname.lastname@example.org, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.