GlobeNewswire Inc | Mar 3, 2021 10:16AM EST

March 03, 2021

NEW YORK, March 03, 2021 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Aquestive Therapeutics, Inc. (Aquestive) (NASDAQ: AQST) in the United States District Court for the District of New Jersey on behalf of those who purchased or acquired the securities of Aquestive between December 2, 2019, through September 25, 2020, inclusive (the Class Period). The lawsuit seeks to recover damages for investors under the federal securities laws.

The Complaint alleges that Defendants made materially false and/or misleading statements, as well as failed to disclose to investors: (1) data included in the Libervant NDA submission showed a lower drug exposure level than desired for certain weight groups; (2) the foregoing significantly decreased the Libervant NDAs approval prospects; (3) as a result, it was foreseeable that the FDA would not approve the Libervant NDA in its current form; and (4) as a result, the Companys public statements were materially false and misleading at all relevant times.

On September 25, 2020, the Company 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. The Company 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, the Companys stock price fell $2.64 per share, or 34.69%, to close at $4.97 per share on September 28, 2020.

Investors who purchased or otherwise acquired shares of Aquestive during the Class Period should contact the Firm prior to the April 30, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Please visit our website at http://www.gme-law.com for more information about the firm.