See Why Aquestive Therapeutics Shares Are Down More Than 30%

The FDA has notified Aquestive Therapeutics Inc AQST that the agency is still considering the regulatory issues related to the approvability of Libervant and will not be ready to take action by December 23, 2021.
The agency did note that no additional information is needed. It also said that it is currently unable to estimate the timing of an expected action.
Libervant is a buccally (inside of the cheek) administered soluble film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients with epilepsy 12 years of age and older.
Related content: Benzinga's Full FDA Calendar.
The Company continues to advance AQST-109 as it began the EPIPHAST study for allergic reactions. The results are expected to be available in 1H of 2022.
AQST-109 is a polymer matrix-based film that can be applied sublingually (under the tongue) for the rapid delivery of epinephrine. The product is similar to a postage stamp and begins to dissolve on contact.
No water or swallowing is required for administration.
Price Action: AQST shares are down 32.5% at $4.20 during the premarket session on the last check Tuesday.