Aquestive Therapeutics, Inc. (AQST) Misled Investors About the Likelihood of Approval of its New Drug Application for Libervant
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”). During the relevant period, Aquestive expressed that the process for obtaining FDA approval was on target and “as expected.”
On September 25, 2019, 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. Aquestive informed shareholders, “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 over 34.69%, to close at $4.97 per share on September 28, 2020.