Aquestive Therapeutics Inc. (AQST)
NASDAQ (NMS) NASDAQ (NMS) Primary Summary
Aquestive: FDA Acceptance Of Anaphylm Resubmission Makes For Rating Upgrade
Aquestive Therapeutics received FDA acceptance for the Anaphylm NDA resubmission, targeting a March 16, 2027 PDUFA date. Resubmission addresses prior FDA concerns with improved human factors data, showing a significant reduction in packaging and administration errors. I upgrade AQST to Buy, anticipating Anaphylm approval and potential >$250m annual revenue by 2030, despite competitive and reimbursement risks.
Aquestive Therapeutics, Inc. (AQST) Q2 2026 Earnings Call Transcript
Aquestive Therapeutics, Inc. (AQST) Q2 2026 Earnings Call Transcript
Aquestive Therapeutics Q2 Earnings Call Highlights
Aquestive Therapeutics NASDAQ: AQST said it plans to resubmit its new drug application for Anaphylm, its epinephrine sublingual film candidate for type 1 allergic reactions including anaphylaxis, before the end of the third quarter after completing studies requested by the U.S. Food and Drug Administration.
Aquestive Therapeutics Inc. Investors
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| BZ Brandon Zatopek Commonwealth Equity Services LLC | 1.05M | $5.26M | $4.82M | -$439,393.5 | -8.35% |
| JD Jim Dushek HARBOUR INVESTMENTS Inc. | 576 | $2,390.4 | $2,655.36 | $264.96 | 11.08% |
| BG Bart Gancher Intech Investment Management LLC | 39,869 | $195,662.69 | $161,868.14 | -$33,794.55 | -17.27% |
| JRP Jay R. Petschek Corsair Capital Management LP | 70,000 | $429,100 | $277,795 | -$151,305 | -35.26% |
| GD Gary Dalton Latash Investments LLC | 243,134 | $965,241.98 | $934,850.23 | -$30,391.75 | -3.15% |
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Aquestive Therapeutics Inc. Profile
| Specialty Retail Industry | Consumer Discretionary Sector | Daniel Barber CEO | NASDAQ (NMS) Exchange | 03843E104 CUSIP |
| US Country | 147 Employees | - Last Dividend | - Last Split | 25 Jul 2018 IPO Date |
Overview
Aquestive Therapeutics, Inc. is a prominent pharmaceutical company with operations both in the United States and internationally. Since its incorporation in 2004, the company has been committed to enhancing patient outcomes through the development and marketing of advanced pharmaceutical therapies. Headquartered in Warren, New Jersey, Aquestive Therapeutics specializes in creating innovative drug delivery systems, notably oral soluble film formulations, that aim to improve the efficacy, safety, and convenience of existing medications. Their unique approach targets a variety of complex medical conditions, from neurological disorders to opioid dependence, offering new hope and improved treatment options for patients around the globe.
Products and Services
Aquestive Therapeutics, Inc. offers an impressive portfolio of marketed products alongside a dynamic pipeline of proprietary product candidates focused on solving unmet medical needs through advanced drug delivery technologies:
- Sympazan: An oral soluble film formulation of clobazam designed for the treatment of Lennox-Gastaut syndrome, a severe form of epilepsy. This innovative approach enhances patient compliance, particularly in children and adults who experience difficulties with traditional pill forms.
- Suboxone: A sublingual film formulation combining buprenorphine and naloxone to address opioid dependence. This product represents a critical tool in the battle against opioid addiction, offering a safer, more convenient alternative to oral medications.
- Zuplenz: An oral soluble film formulation of ondansetron for the prevention of nausea and vomiting associated with chemotherapy and post-operative recovery. Zuplenz simplifies administration, particularly for patients who cannot swallow pills due to their medical condition.
- Azstarys: A once-daily product for the management of attention deficit hyperactivity disorder (ADHD). Azstarys aims to provide consistent symptom control throughout the day, improving the quality of life for individuals with ADHD.
- Libervant: Proprietary buccal soluble film formulation of diazepam for the management of seizure episodes. This product candidate is designed for rapid absorption and onset of action, providing a novel option for seizure management.
- KYNMOBI: A sublingual film formulation of apomorphine for the swift alleviation of episodic off-periods in Parkinson's disease. KYNMOBI addresses an unmet need for patients seeking rapid relief from these debilitating symptoms.
- Exservan: An oral soluble film formulation of riluzole intended for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Exservan provides a unique administration route for patients with difficulties swallowing.
- AQST-108: A novel sublingual film formulation delivering systemic epinephrine for conditions requiring immediate treatment beyond anaphylaxis. This innovative approach aims to expand the use of epinephrine for emergency treatments.
- Anaphylm: An epinephrine sublingual film for the emergency treatment of allergic reactions, including anaphylaxis. Anaphylm embodies the company’s commitment to advancing patient care in acute emergency situations.
- Adrenaverse: A proprietary epinephrine prodrug platform currently under development. This groundbreaking technology could redefine the treatment landscape for emergency management of severe allergic reactions.
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