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Biotech Stocks Facing FDA Decision In September

Aquestive Therapeutics
Aquestive Therapeutics

Aquestive Therapeutics Inc.’s (AQST) lead drug candidate Libervant, which is at the FDA altar, awaits a decision on September 27, 2020.

Libervant is a soluble film formulation of diazepam, administered inside of the cheek and is intended for rapid treatment of acute uncontrolled seizures in refractory patients with epilepsy on stable anti-epileptic drugs.

The current standard of care rescue therapy for patients with refractory epilepsy is Diastat, a diazepam based rectal gel that is invasive, inconvenient, and difficult to administer.

If approved by the FDA, Libervant will an alternative to Diastat and will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients.

AQST closed Wednesday’s (Aug.26, 2020) trading at $8.10, up 1.44%.