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Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Welcome to our dedicated page for Aquestive Therapeutics news (Ticker: AQST), a resource for investors and traders seeking the latest updates and insights on Aquestive Therapeutics stock.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a specialty pharmaceutical company dedicated to developing and commercializing innovative medicines designed to solve critical healthcare challenges. By focusing on patient-centric solutions, Aquestive aims to improve the lives of individuals managing complex diseases. The company's core area of expertise lies in the Central Nervous System (CNS) and severe allergic reactions, including anaphylaxis.

Core Business and Products
Aquestive Therapeutics leverages its proprietary drug delivery technologies to create novel oral treatments that offer convenient alternatives to invasive, conventional therapies. The company’s commercial product portfolio includes:

  • Sympazan Oral Film - A treatment for seizures associated with Lennox-Gastaut Syndrome.
  • Suboxone Sublingual Film - Utilized in opioid addiction management.
  • Exservan Oral Film - A medication for Amyotrophic Lateral Sclerosis (ALS).
  • Zuplenz - An antiemetic to prevent nausea and vomiting.

Pipeline and Recent Developments
Aquestive's robust pipeline includes late-stage candidates such as:

  • Libervant Buccal Film - Positioned to address seizure clusters in epilepsy patients.
  • AQST-108 - A sublingual film for the treatment of anaphylaxis.
  • AQST-305 - A developing solution for severe allergic reactions.

The company has made significant strides with its proprietary PharmFilm® technology, enhancing drug delivery effectiveness and patient compliance. Aquestive collaborates with other pharmaceutical entities to bring these advanced treatments to market. Recent achievements include pivotal trials and regulatory submissions that underscore the company's commitment to addressing unmet medical needs.

Financial Overview
Aquestive Therapeutics predominantly earns its revenue from the United States through product sales and licensing agreements. The company’s latest financial reports indicate stable growth prospects, driven by its innovative product offerings and strong pipeline.

Partnerships and Market Presence
Aquestive actively partners with leading pharmaceutical firms to expand its reach and impact. The company's collaborations enable the development and commercialization of breakthrough treatments, further establishing its presence in the global pharmaceutical landscape.

For more information, recent updates, and investor inquiries, please visit the company’s official website or contact their investor relations team.

Rhea-AI Summary

Aquestive Therapeutics, Inc. (NASDAQ: AQST) received tentative FDA approval for Libervant™ (diazepam) Buccal Film, aimed at treating acute seizure clusters in patients with epilepsy aged 12 and older. However, marketing is currently restricted due to the orphan drug exclusivity of Valtoco®, a competing product. Company CEO Daniel Barber expressed optimism about Libervant's potential and plans to engage further with the FDA regarding market access. The company also aims to advance its AQST-109 product for severe allergic reactions.

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Aquestive Therapeutics (Nasdaq: AQST) announced key leadership changes, appointing Timothy E. Morris to the Board of Directors and Kenneth Truitt, M.D., as Chief Medical Officer. Morris brings over 35 years of experience in executive leadership and will join the Audit Committee. Truitt, effective September 6, 2022, has over 25 years of clinical experience and aims to advance AQST-109, targeting the emergency treatment of allergic reactions. Both appointments aim to strengthen the company's pipeline and regulatory engagement, particularly with the FDA.

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Aquestive Therapeutics reported second quarter 2022 financial results, revealing total revenues of $13.3 million, down from $15.3 million in Q2 2021, despite a 36% surge in revenue from its product Sympazan. The company's net loss widened to $16.3 million or $0.36 per share, compared to a $12.4 million loss, primarily due to increased R&D expenses for AQST-109. However, the firm has updated its full-year revenue guidance to $46-$49 million, up from $42-$47 million, and maintains a positive outlook for its product development and FDA dialogues.

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Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the Wedbush PacGrow Healthcare Conference set for August 9-10, 2022. The management team will host a fireside chat on August 9 at 10:55 am ET and conduct investor meetings until August 10. A webcast of the chat will be available for 30 days on the company's website.

Aquestive focuses on developing innovative orally administered products, including its proprietary Sympazan® for seizures. The company is advancing a pipeline targeting CNS diseases and severe allergic reactions.

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Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it will report its second-quarter results for the period ended June 30, 2022, on August 2, 2022, after market close. Investors can join a conference call on August 3, 2022, at 8:00 a.m. ET, after prior registration. The company focuses on innovative delivery methods for complex molecules and has five commercialized products and a late-stage pipeline targeting central nervous system diseases and severe allergic reactions. For more information, visit Aquestive's website.

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Aquestive Therapeutics (AQST) announced positive topline results from Part 3 of the EPIPHAST study for AQST-109, an epinephrine oral film. Key findings showed a consistent Tmax of 12 minutes for sublingual administration after consuming a peanut butter sandwich, with comparable pharmacokinetics to previous datasets. In addition, swallowing the film whole with water resulted in unexpectedly high gastrointestinal absorption, indicating improved compliance potential. The ongoing EPIPHAST II study will compare AQST-109 to standard epinephrine injection methods.

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Aquestive Therapeutics (AQST) announced promising results from the EPIPHAST study for AQST-109, an oral film for anaphylaxis treatment. The study demonstrated a median time to maximum concentration (Tmax) of 12 minutes, significantly faster than traditional EpiPen's 50 minutes. AQST-109 shows favorable pharmacokinetics and safety profiles. An upcoming head-to-head study with EpiPen is set for Q3 2022, with plans to seek an End-of-Phase 2 meeting with the FDA shortly thereafter.

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Aquestive Therapeutics (NASDAQ: AQST) has completed a registered direct offering, raising approximately $8.5 million by selling 8,850,000 shares at $0.96 each to an institutional investor and $1.09 for its executives. The warrants issued are exercisable after six months at a price of $0.96. CEO Daniel Barber emphasized the focus on profitability and cash generation amidst market challenges, particularly regarding the FDA review of Libervant and the development of AQST-109. The offering is executed under Form S-3 registration with the SEC.

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Aquestive Therapeutics (NASDAQ: AQST) announced participation in the JMP Securities Life Sciences Conference on June 15-16, 2022. The management team will conduct a fireside chat on June 16 at 9:00 am ET and hold investor meetings throughout the conference. A webcast of the presentation will be available on the company's Investor Relations website for 30 days post-event. Aquestive focuses on developing innovative oral medications to enhance patient care, with five products currently on the market, including Sympazan® for seizure treatment.

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Aquestive Therapeutics (NASDAQ: AQST) announced a definitive agreement for a registered direct offering of 8,850,000 shares of common stock and warrants, generating approximately $8.5 million in gross proceeds. Shares will be sold at $0.96 each to a healthcare-focused institutional investor and at $1.09 to certain executives. The offering is expected to close around June 8, 2022, pending customary conditions. The funds will be allocated for general corporate purposes. A.G.P./Alliance Global Partners is the sole placement agent for this offering.

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FAQ

What is the current stock price of Aquestive Therapeutics (AQST)?

The current stock price of Aquestive Therapeutics (AQST) is $4.56 as of November 22, 2024.

What is the market cap of Aquestive Therapeutics (AQST)?

The market cap of Aquestive Therapeutics (AQST) is approximately 418.1M.

What does Aquestive Therapeutics, Inc. specialize in?

Aquestive Therapeutics specializes in developing and commercializing medicines for treating diseases of the Central Nervous System (CNS) and severe allergic reactions.

What are some of the key products in Aquestive Therapeutics' portfolio?

Key products include Sympazan Oral Film, Suboxone Sublingual Film, Exservan Oral Film, and Zuplenz.

What is the PharmFilm® technology?

PharmFilm® is Aquestive Therapeutics' proprietary drug delivery technology that enhances drug effectiveness and patient compliance through innovative oral film formulations.

What is Libervant Buccal Film used for?

Libervant Buccal Film is designed to treat seizure clusters in epilepsy patients.

Where does Aquestive Therapeutics derive most of its revenue from?

The majority of Aquestive Therapeutics' revenue comes from the United States.

What is AQST-108?

AQST-108 is an investigational sublingual film for the treatment of severe allergic reactions, including anaphylaxis.

How does Aquestive Therapeutics collaborate with other pharmaceutical companies?

Aquestive collaborates with other pharmaceutical companies to develop and commercialize new molecules using its proprietary technologies.

What recent developments has Aquestive Therapeutics achieved?

Recent developments include pivotal trials and regulatory submissions for its pipeline products, highlighting its progress towards addressing unmet medical needs.

Who are the primary partners in Aquestive Therapeutics' recent offering?

Leerink Partners and Piper Sandler acted as joint bookrunning managers, with Oppenheimer & Co. as the lead manager for the recent offering.

How can investors get more information about Aquestive Therapeutics?

Investors can visit the company's official website or contact their investor relations team for more information and updates.

Aquestive Therapeutics, Inc.

Nasdaq:AQST

AQST Rankings

AQST Stock Data

418.05M
86.22M
5.01%
52.43%
11.13%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
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