March 01, 2021 - An investor in shares of Aquestive Therapeutics, Inc. (NASDAQ: AQST) filed a lawsuit in the U.S. District Court for the District Court for the District of New Jersey over alleged violations of Federal Securities Laws by Aquestive Therapeutics, Inc. in connection with certain allegedly false and misleading statements made between December 2, 2019 and September 25, 2020.
Warren, NJ based Aquestive Therapeutics, Inc., a pharmaceutical company, focuses on identifying, developing, and commercializing various products to address unmet medical needs in the United States and internationally. Aquestive Therapeutics, Inc. reported that its annual Total Revenue declined from $67.43 million in 2018 to $52.6 million in 2019, and that its Net Loss increased from $61.37 million in 2018 to $61.35 million in 2019.
On December 2, 2019, Aquestive Therapeutics, Inc. 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 ). On September 25, 2020, Aquestive Therapeutics, Inc. 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 Therapeutics, Inc. 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. Shares of Aquestive Therapeutics, Inc. (NASDAQ: AQST) declined from $9.46 per share on September 11, 2020, to as low as $4.38 per share on October 2, 2020. According to the complaint the plaintiff alleges on behalf of purchasers of Aquestive Therapeutics, Inc. (NASDAQ: AQST) common shares between December 2, 2019 and September 25, 2020, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between December 2, 2019 and September 25, 2020, the 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 data included in the Libervant NDA submission showed a lower drug exposure level than desired for certain weight groups, that the foregoing significantly decreased the Libervant NDA's approval prospects, that as a result, it was foreseeable that the FDA would not approve the Libervant NDA in its current form, and that as a result, the Company's public statements were materially false and misleading at all relevant times.