NEW YORK, Jan. 13, 2022 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that it is investigating whether the directors and/or officers of Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ: AQST) breached their fiduciary duties of loyalty, good faith and candor and whether the Company suffered substantial harm as a result.
According to a complaint filed on behalf of purchasers of Aquestive securities, 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”). During the relevant period, Aquestive expressed that the process for obtaining FDA approval was on target and “as expected.”
On September 25, 2019, Aquestive announced receipt of a Complete Response Letter 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. Aquestive informed shareholders, “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 over 34.69%, to close at $4.97 per share on September 28, 2020.
If you are an investor in Aquestive securities and wish to discuss your rights or if you are aware of any facts relating to this investigation, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or
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