NEW YORK, March 1, 2021 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") (NASDAQ: AQST) and certain of its officers. The class action, filed in United States District Court for the District of New Jersey, and docketed under 21-cv-03751, is 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 (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Aquestive securities during the Class Period, you have until April 30, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Aquestive was founded in 2004 and is headquartered in Warren, New Jersey. Aquestive is a specialty pharmaceutical company that focuses on identifying, developing, and commercializing various products to address unmet medical needs. 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").
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose 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.
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.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
SOURCE Pomerantz LLP