LOS ANGELES, March 24, 2021 /PRNewswire/ -- The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") (NASDAQ: AQST) securities between December 2, 2019 and September 25, 2020, inclusive (the "Class Period"). Aquestive investors have until April 30, 2021 to file a lead plaintiff motion.
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Aquestive is a specialty pharmaceutical company. Its most advanced proprietary product candidate is Libervant, 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.
On September 25, 2020, Aquestive announced receipt of a Complete Response Letter ("CRL") from the FDA stating that the NDA would not be approved in its current form. According to the CRL, "in a study submitted by the Company with the NDA, certain weight groups showed a lower drug exposure level than desired." The Company stated that it "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 approximately 35%, to close at $4.97 per share on September 28, 2020.
The complaint filed in this class action alleges that throughout the Class Period, 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 failed to disclose to investors that: (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 NDA's 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, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
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If you purchased Aquestive securities during the Class Period, you may move the Court no later than April 30, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased Aquestive securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to firstname.lastname@example.org, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
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SOURCE The Law Offices of Frank R. Cruz, Los Angeles