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Specialty pharmaceutical company: Aquestive Therapeutics, Inc. (AQST)

Aquestive Therapeutics, Inc. (NASDAQ:AQST) was founded in January 2004, formerly known as MonoSol Rx, LLC, and changed to its current name on December 31, 2017. Headquartered in Warren, New Jersey, USA, it has 195 full-time employees (3 /31/2018), is a specialty pharmaceutical company focusing on identifying, developing and commercializing differentiated products to meet unmet medical needs.

Aquestive Therapeutics

Aquestive Therapeutics, Inc. (AQST):

MonoSol Rx, LLC has been operating since January 2004 and has been using this name until December 31, 2017. Since January 2014-October 31, 2017, the company has been a limited liability company (LLC), 2017 From November 1st to December 31st, the company operated as a C corporation. Starting from January 1, 2018, the company changed from a Delaware limited company to a Delaware stock company, and was renamed Aquestive Therapeutics, Inc..

Aquestive Therapeutics has a late-stage proprietary product line that focuses on the treatment of central nervous system (CNS) diseases.

Aquestive Therapeutics’ most advanced product candidates, which the company intends to commercialize on its own, include:

  • Libervant (preliminary brand name of AQST-203)-a soluble membrane preparation of diazepam administered intraoral or buccal for the treatment of recurrent seizures. The company expects to submit a new drug application (NDA) in 2018.
  • Sympazan (preliminary brand name of AQST-120)-an oral soluble film preparation clobazam, used to treat seizures associated with rare intractable epilepsy, called Lennox-Gastaut Syndrome (LGS), the company launched in October 2017 The NDA was submitted on August 31, 2018, and it was designated as the Prescription Drug User Fee Act (PDUFA) on August 31, 2018. It is currently waiting for the US Food and Drug Administration (FDA) to complete the review.
  • AQST-117-an oral soluble film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS). The company expects to submit an NDA in the first half of 2019.
  • AQST-108, a film formulation of sublingual epinephrine used to treat allergic reactions, the company plans to start additional phase I trials in 2018.
  • AQST-305, an oral membrane preparation of octreotide, is used to treat acromegaly and neuroendocrine tumors. The company expects to start a human proof concept test in 2018.

In addition to the above candidate products, Aquestive Therapeutics also has a portfolio of cooperative products in the commercialization and development stages, including:

  • Suboxone, a sublingual film formulation of buprenorphine and naloxone, is the market leader in the treatment of opioid dependence.

Aquestive Therapeutics manufactures all cooperative and proprietary products at the FDA and the Drug Enforcement Administration, inspects facilities, and expects that our current production capacity is sufficient to meet the number of commercial products and candidate products currently under development. In the past four years, the company has produced more than 1.1 billion doses of Suboxone. Aquestive Therapeutics’ products are developed using the company’s proprietary PharmFilm technology and proprietary technology. The company’s patent portfolio currently contains at least 200 granted patents worldwide, of which at least 40 are US patents, and there are more than 75 pending patent applications worldwide.

Aquestive Therapeutics, Inc. (AQST) investment:

Aquestive Therapeutics, Inc. (NASDAQ:AQST) submitted its IPO prospectus on 6/27/2018, and listed on NASDAQ on 7/25/2018. The issue price is US$15.00, 4 million shares are issued, and the capital raised does not exceed 60 million. USD, joint underwriting by BMO Capital Markets / RBC Capital Markets .

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