Aquestive Therapeutics, Inc
|Company Name||Aquestive Therapeutics, Inc|
|Class Period||December 02, 2019 to September 25, 2020|
|Lead Plaintiff Motion Deadline||April 30, 2021|
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 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.
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