The Law Offices of Frank R. Cruz announces an investigation of Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ: AQST ) on behalf of investors concerning the Company’s possible violations of federal securities laws.
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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.
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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 info@frankcruzlaw.com , 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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The Law Offices of Frank R. Cruz, Los Angeles
Frank R. Cruz, 310-914-5007
fcruz@frankcruzlaw.com
www.frankcruzlaw.com