AQST - Aquestive sheds a third after receiving FDA response for Libervant application

Aquestive Therapeutics (NASDAQ:AQST) drops 32.8% premarket after receiving FDA notification regarding the review of the New Drug Application (NDA) for Libervant (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters. The notice stated, "the Agency is still considering the regulatory issues related to the approvability of Libervant, and will not be ready to take an action by December 23, 2021. No additional information is needed from you at this time. We are currently unable to provide an estimate of the timing of an expected action; however, we will provide any updates we can as they are available.” The company is currently reaching out to the FDA to seek further clarity. In July 2021, the FDA accepted the NDA for Libervant and assigned a PDUFA target goal date of December 23, 2021. The Company continues to advance AQST-109 as it began the EPIPHAST study, with results expected in H1 2022.

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Aquestive sheds a third after receiving FDA response for Libervant application