LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In April 2024

Aquestive Therapeutics
Aquestive Therapeutics

The FDA decision on Aquestive Therapeutics Inc.’s (AQST) Libervant (diazepam) Buccal Film is due on April 28, 2024.

Libervant Buccal Film is proposed for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients between two and five years of age.

Libervant Buccal Film was given tentative approval by the FDA for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older in August 2022.

But, due to an existing FDA regulatory grant of orphan drug market exclusivity for Neurelis Inc.'s Valtoco, which is also a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States until January 2027.

AQST is currently (Mar.28, 2024) trading at $4.40, up 7.55%.