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Aquestive Therapeutics, Inc. (AQST)

Aquestive Therapeutics, Inc. is a pharmaceutical company focused on discovering, developing, and commercializing products to address significant unmet medical needs across both the United States and international markets. The company's commercialized portfolio includes: Sympazan, an oral soluble film formulation of clobazam for individuals with Lennox-Gastaut syndrome. Suboxone, a sublingual film containing buprenorphine and naloxone, indicated for the treatment of opioid dependence. Zuplenz, an oral soluble film of ondansetron, used to manage nausea and vomiting associated with chemotherapy and post-operative recovery. Azstarys, a once-daily medication for attention deficit hyperactivity disorder. Aquestive maintains a robust proprietary pipeline of drug candidates. These include: Libervant, a buccal soluble film formulation of diazepam currently in development for the treatment of seizures. Exservan, an oral soluble film of riluzole, aimed at treating amyotrophic lateral sclerosis (ALS). Within its complex molecule pipeline, the company is advancing: AQST-108, a sublingual film designed to deliver systemic epinephrine for conditions other than anaphylaxis. AQST-305, a sublingual film formulation of octreotide for managing acromegaly. AQST-109, an orally administered epinephrine product candidate intended for the emergency treatment of severe allergic reactions, including anaphylaxis. Furthermore, Aquestive Therapeutics played a role in the development of KYNMOBI, a sublingual film formulation of apomorphine, used to address episodic "off" periods in patients with Parkinson's disease. Established in 2004, Aquestive Therapeutics, Inc. is headquartered in Warren, New Jersey.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

Aquestive Therapeutics, Inc. logo

Aquestive Therapeutics, Inc.

NASDAQ:AQSTHealthcare
-3.71%$3.89
AH$3.95+1.42%vs close
Mkt Cap$488.24M
Float107.68M
O/S125.51M
Vol
$ Vol
RVOL
Inst Own57.0%
SI25.6%
Earnings
Dilution
Upcoming Catalysts
  • Type I allergic reactions, including anaphylaxis
    Cash runway at this date: 13mo
    Mar 16, 2027in 134 days8-K
  • seizure clusters in patients with epilepsy ages 6 to 11 (label expansion)
    Cash runway at this date: 13mo
    Mar 29, 2027in 147 days8-K
  • expansion of label to add ages 6 to 11 for acute treatment of seizure clusters in epilepsy
    Cash runway at this date: 13mo
    Mar 29, 2027in 147 days8-K
Phase Distribution
11 lead-sponsored trials·0 active·9 completed
Phase 13
Phase 1/22
Phase 25
Phase 31

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Completed

    Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy

    Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category

    Epilepsy

    Enrollment
    149
    Start
    Jan 2018
    Primary Completion
    Jun 2020
    Completion
    Jun 2020
    NCT03428360
  • Phase 2
    Completed

    Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy

    Diazepam Buccal Film 12.5 mg

    Epilepsy

    Enrollment
    35
    Start
    May 2017
    Primary Completion
    Jul 2018
    Completion
    Dec 2018
    NCT03179891
  • Phase 2
    Completed

    Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy

    Diazepam Buccal Film

    Epilepsy

    Enrollment
    24
    Start
    Aug 2017
    Primary Completion
    Jan 2020
    Completion
    Mar 2020
    NCT03222349
  • Phase 2
    Withdrawn

    Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

    Riluzole Oral Soluble Film

    ALS

    Enrollment
    0
    Start
    Mar 2018
    Primary Completion
    Mar 2018
    Completion
    Mar 2018
    NCT03457753
  • Phase 2
    Terminated

    Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)

    Riluzole Oral Soluble film (ROSF) 50 mg

    Amyotrophic Lateral Sclerosis

    Enrollment
    9
    Start
    Apr 2018
    Primary Completion
    Sep 2018
    Completion
    Dec 2018
    NCT03679975
  • Phase 2
    Completed

    Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome

    DESF, Epinephrine Injection

    Allergic Reaction

    Enrollment
    36
    Start
    Jul 2024
    Primary Completion
    Oct 2024
    Completion
    Oct 2024
    NCT06527937
  • Phase 1/2
    Completed

    Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

    Ondansetron (ODFS), Zofran (ODT)

    Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced

    Enrollment
    48
    Start
    Sep 2008
    Primary Completion
    Sep 2008
    Completion
    Oct 2008
    NCT01217190
  • Phase 1/2
    Completed

    Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study

    Diazepam Buccal Film, Diastat® Rectal Gel (Valeant Pharmaceuticals USA)

    Epilepsy

    Enrollment
    31
    Start
    Apr 2019
    Primary Completion
    Jul 2019
    Completion
    Jul 2019
    NCT03953820
  • Phase 1
    Completed

    Two Way Bioequivalence Study Under Fed Conditions

    Ondansetron (ODFS), Ondansetron (ODT)

    Healthy

    Enrollment
    48
    Start
    Oct 2008
    Primary Completion
    Oct 2008
    Completion
    Oct 2008
    NCT01217801
  • Phase 1
    Completed

    Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

    Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water

    Healthy Participants

    Enrollment
    18
    Start
    Aug 2008
    Primary Completion
    Aug 2008
    Completion
    Aug 2008
    NCT01220167
  • Phase 1
    Completed

    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects

    DESF

    Allergic Reaction

    Enrollment
    32
    Start
    Dec 2024
    Primary Completion
    Mar 2025
    Completion
    May 2025
    NCT07703982