AQST Soars On FDA Approval

(RTTNews) - Shares of Aquestive Therapeutics, Inc. (AQST) are up 21.15% in pre-market trading on Monday, following FDA approval of its drug Exservan for the treatment of neurological disorder amyotrophic lateral sclerosis (ALS).

The approval news was announced after-hours on Friday. The original decision date was November 30, 2019.

Exservan is an oral film formulation of Riluzole, the first FDA-approved medication for amyotrophic lateral sclerosis, which has been available as 50 mg tablets since December 1995.

The approved treatments for amyotrophic lateral sclerosis cannot completely cure, halt, or reverse the progression of the disease, but can help ease specific symptoms and slow its progression.

Amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease, is a progressive and fatal neuromuscular disease.

Early symptoms of ALS usually include muscle weakness or stiffness. Gradually all muscles under voluntary control are affected, and individuals lose their strength and the ability to speak, eat, move, and even breathe.

Most people with ALS die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. But legendary scientist Stephen Hawking, who was diagnosed with ALS at the age of 21, was able to survive the disease for 55 more years. He died on March 14, 2018, at the age of 76.

On November 13, 2019, the company announced that it licensed Exservan to Italian pharma company Zambon S.p.A. for the development and commercialization in the European Union for the treatment of amyotrophic lateral sclerosis (ALS).

Positive topline results from the recently completed single-dose crossover study for Libervant (diazepam) Buccal Film, which is in development for the management of select patients with refractory epilepsy who require treatment to control episodes of increased seizure activity, or "seizure clusters" were was reported in August. Aquestive Therapeutics expects to file NDA in the fourth quarter of 2019.

In the third quarter of 2019, Aquestive's net loss was $18.4 million, or $0.74 per share versus net loss of $15.0 million, or $0.64 per share in the same quarter a year ago. Analysts were expecting a loss of $0.69 per share. Total revenues were $12.4 million in the third quarter compared with $13.3 million last year.