Aquestive Therapeutics Inc

Aquestive Therapeutics, Inc. engages in the identifying, developing, and commercializing differentiated products to address unmet medical needs and to solve patients’ therapeutic problems. Its product pipeline include Libervant, AQST-108, AQST-305, Suboxone and Zuplenz. The company was founded in January 2004 and is headquartered in Warren, NJ.

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Aquestive Therapeutics reports robust 2022 performance and strategic growth plans

Aquestive Therapeutics showcased strong performance in 2022, focusing on innovation, strategic partnerships, and financial management.
While facing challenges such as generic competition and financial discipline, the company is well-positioned to capitalize on opportunities for growth and market expansion.
With a clear emphasis on advancing key products, securing collaborations, and navigating market dynamics, Aquestive is poised for continued success in 2023 and beyond.

Aquestive Therapeutics reports strong Q1 performance and eyes global expansion

Aquestive Therapeutics' Q1 performance reflects strong revenue growth, debt reduction, and strategic advancements in product development.
While facing challenges in European pricing and Chinese market visibility, the company maintains a focus on operational efficiency and market expansion.
Opportunities in FDA interactions, market access, and upcoming regulatory meetings position Aquestive for future growth and product success.
Overall, Aquestive Therapeutics demonstrates resilience and strategic planning in navigating market challenges and driving growth.

Aquestive Therapeutics reports improved Q2 performance and eyes global expansion

Aquestive Therapeutics reported a strong Q2 2023 performance with revenue growth and reduced net loss. The company faces financial challenges but holds strengths in its financial position and growth outlook. Opportunities for expansion and partnerships present avenues for future growth.

Aquestive Therapeutics reports strong Q3 performance and optimistic growth outlook

Aquestive Therapeutics showcased robust financial performance, strategic debt refinancing, and promising product developments in Q3 2023. While facing challenges in competitive intelligence and trial efficiency, the company is optimistic about future growth opportunities and remains focused on expanding its capabilities.

Aquestive reports robust Q4 earnings, eyes billion-dollar sales opportunities

Aquestive Therapeutics showcases strong financial performance in Q4 2023, with revenue growth and improved EBITDA loss, setting a positive trajectory for future growth. Strategic focus on launching Anaphylm and Libervant, along with proactive commercial preparations, underlines the company's commitment to innovation and market expansion. Despite regulatory and competitive challenges, Aquestive's confidence in FDA processes and international market exploration present promising opportunities for long-term success.

Aquestive Therapeutics reports revenue growth and plans for future launches

Aquestive Therapeutics reported revenue growth in Q3 2024 driven by successful product launches and positive study results, despite increased expenses.
The company's focus on key programs and upcoming milestones signals a commitment to innovation and addressing market needs for sustained growth.
While facing challenges in managing expenses and profitability, Aquestive's strong financial position and strategic initiatives offer opportunities for future growth and market expansion.
Overall, Aquestive's performance in Q3 2024 reflects a balance between investment in future growth and financial stability, positioning the company for continued success.

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Aquestive Therapeutics Inc. (NASDAQ: AQST) has announced that it had received a Complete Response Letter (CRL) from the U.S.

Should Aquestive Therapeutics Be Worried About This FDA Response?

WARREN, N.J., Sept.  25, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for management of seizure clusters. The FDA issues a CRL to indicate that the review cycle for an application is complete but the application cannot be approved in its current form.

Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant™ (diazepam) Buccal Film for Management of Seizure Clusters

WARREN, N.J., Aug.  20, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today the initiation of a Phase 1 Pharmacokinetic (PK) trial for the Company’s drug candidate AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of allergic reactions (Type 1), including anaphylaxis, using Aquestive’s proprietary PharmFilm® technologies. 

Aquestive Therapeutics Initiates Phase 1 Pharmacokinetic Trial of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) In Development for Treatment of Allergic Reactions Including Anaphylaxis

Aquestive Therapeutics (AQST) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.

Aquestive Therapeutics (AQST) in Focus: Stock Moves 6.4% Higher

WARREN, N.J., Aug.  10, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s drug candidate AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of allergic reactions (Type 1), including anaphylaxis, using Aquestive’s proprietary PharmFilm® technologies. 

Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Treatment of Allergic Reactions Including Anaphylaxis

Aquestive Therapeutics, Inc. (AQST) CEO Keith Kendall on Q2 2020 Results - Earnings Call Transcript

WARREN, N.J., July  28, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that management will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference to be held August 11-12, 2020.  Aquestive will present on August 11 at 9:45 am EDT and is available for one-on-one meetings during the conference.

Aquestive Therapeutics to Present at 2020 Wedbush PacGrow Healthcare Virtual Conference

WARREN, N.J., July  15, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will report results for the second quarter ended June 30, 2020 and provide a business update after market close on Tuesday, August 4, 2020.

Aquestive Therapeutics to Announce Second Quarter Financial Results and Recent Business Highlights on Aug 4 and Host Conference Call on Aug 5 at 8:00 a.m. ET

WARREN, N.J., June  29, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for pharmacokinetic (PK) clinical trials of its drug candidate AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies. The Company intends to initiate its planned PK trials before the year end 2020.

Aquestive Therapeutics Files IND for Pharmacokinetic Clinical Trials of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment

WARREN, N.J., June  16, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that management will present at the BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference to be held virtually on Tuesday, June 23, 2020.  Aquestive will present at 8:30 am EDT and is available for one-on-one meetings during the conference.

Aquestive Therapeutics to Present at BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference

Aquestive Therapeutics (AQST) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

Why Aquestive Therapeutics (AQST) Stock Might be a Great Pick

WARREN, N.J., May  21, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced plans to advance its strategy to monetize the anticipated royalties associated with Sunovion Pharmaceuticals’ apomorphine sublingual film APL-130277, which received FDA approval to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease.

Aquestive Therapeutics Advances Royalty Monetization Plan as Sunovion Pharmaceuticals’ Apomorphine Sublingual Film Therapy Receives FDA Approval

Is  (AQST) Outperforming Other Medical Stocks This Year?

Is Aquestive Therapeutics (AQST) Outperforming Other Medical Stocks This Year?

As of late, it has definitely been a great time to be an investor in Aquestive Therapeutics.

Aquestive Therapeutics' Shares March Higher, Can It Continue?

Aquestive Therapeutics (AQST) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

All You Need to Know About Aquestive Therapeutics (AQST) Rating Upgrade to Buy

Aquestive Therapeutics, Inc. (AQST) CEO Keith Kendall on Q1 2020 Results - Earnings Call Transcript

Aquestive: Still Looking To Buy In 2020

Aquestive Therapeutics (AQST): Strong Industry, Solid Earnings Estimate Revisions

Aquestive Therapeutics, Inc. (AQST) CEO Keith Kendall on Q4 2019 Results - Earnings Call Transcript

WARREN, N.J., Feb.  10, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that, as anticipated, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020.  If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients.  Libervant was designated by the FDA as an orphan drug in November 2016.

Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film

WARREN, N.J., Feb.  06, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, announced today that it had a constructive face-to-face pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for its drug candidate, AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies.

Aquestive Therapeutics Announces FDA Confirmed 505(b)(2) Pathway for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment

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Aquestive Therapeutics Inc. (NASDAQ: AQST) shares lost nearly a third on Monday after the firm received an update from the U.S. Food and Drug Administration (FDA).

Why Aquestive Therapeutics’ Seizure Treatment May Get Butted Out

WARREN, N.J., Jan.  12, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today reported that the U.S. Food and Drug Administration (FDA) issued a response letter (Response) dated January 10, 2020 denying Aquestive’s Citizen’s Petition received by the FDA on November 1, 2019, including the supplement to the Citizen’s Petition received by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition).  The Petition requested, among other things, that the FDA stay approval of a New Drug Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until additional clinical studies were conducted.  In the Response, the FDA indicated that it had approved Neurelis’s NDA for Valtoco on January 10, 2020.  Valtoco has received orphan drug exclusivity from the FDA’s Center for Drug Evaluation and Research commencing as of January 10, 2020 for the labeled indication of acute treatment of intermittent stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy six years of age and older.

Aquestive Therapeutics Receives FDA Response to Citizen’s Petition

WARREN, N.J., Jan.  10, 2020  (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today reported anticipated preliminary unaudited total revenues for the fourth quarter and full year ended December 31, 2019 and provided initial full year 2020 guidance.

Aquestive Therapeutics Exceeds Top End of Guidance Range for Preliminary Unaudited Full Year 2019 Total Revenues and Provides Initial Full Year 2020 Guidance

News for Aquestive Therapeutics Inc Stock (AQST)