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.

Earnings data Q1 2021

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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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The FDA has notified Aquestive Therapeutics Inc (NASDAQ: AQST) that the agency is still considering the regulatory issues related to the approvability of Libervant and will not be ready to take action by December 23, 2021.  The agency did note that no additional information is needed.

See Why Aquestive Therapeutics Shares Are Down More Than 30%

SAN DIEGO & WARREN, N.J.--(BUSINESS WIRE)---- $AQST #Libervant--Aquestive Therapeutics, Inc. (AQST) May Have Misled Investors About the Likelihood of Approval of its New Drug Application for Libervant

SHAREHOLDER ALERT: Robbins LLP Investigates Aquestive Therapeutics, Inc. (AQST) on Behalf of Shareholders

The stock price of Aquestive Therapeutics, Inc. (NASDAQ: AQST) fell by over 30% pre-market today. This is why it happened.

Aquestive Therapeutics Stock (AQST): Why The Price Substantially Fell Today

WARREN, N.J., Dec. 20, 2021 (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, regarding the review of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters, the U.S. Food & Drug Administration (FDA) sent the following notice to the Company;

Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company's NDA for Libervant™ (diazepam) Buccal Film

Investors need to pay close attention to Aquestive Therapeutics (AQST) stock based on the movements in the options market lately.

Implied Volatility Surging for Aquestive Therapeutics (AQST) Stock Options

WARREN, N.J., Dec. 17, 2021 (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 announced that NASDAQ has added the company to the NASDAQ Biotechnology Index® (Nasdaq: NBI) effective December 20, 2021.

Aquestive Therapeutics Added to NASDAQ Biotechnology Index

Aquestive Therapeutics is moving closer to Libervant's PDUFA date in December. If approved, Aquestive will finish 2021 on a bullish note that can be sustained into 2022. Aquestive has fought through COVID-19 headwinds and was able to report a strong beat on Q3 with SYMPAZAN continuing to show strong growth over the past 11 consecutive quarters.

Aquestive Therapeutics: Looking To End 2021 On A Bullish Note

Aquestive Therapeutics, Inc. (AQST) CEO Keith Kendall on Q3 2021 Results - Earnings Call Transcript

WARREN, N.J., Nov. 02, 2021 (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 reported financial results for the third quarter ended September 30, 2021 and provided an update on recent developments in its business.

Aquestive Therapeutics Reports Third Quarter 2021 Financial Results, Provides Business Update and Improves Full Year Guidance

WARREN, N.J., Oct. 25, 2021 (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 positive topline data from its first-in-human Phase 1 PK study of AQST-109 sublingual film for the delivery of epinephrine in the emergency treatment of allergic reactions including anaphylaxis. Findings from this study support AQST-109's potential as the first orally administered epinephrine treatment for anaphylaxis, with safety, tolerability, PK and pharmacodynamics (PD) measures that fall within the target range of standard of care autoinjectors such as epinephrine pens which require patients or caregivers to inject into their thighs during an emergency allergic reaction.

Aquestive Therapeutics Reports Positive Topline Data from Phase 1 Pharmacokinetic Trial of AQST-109 (epinephrine prodrug sublingual film) Supporting its Development as an Oral Alternative to Epinephrine Autoinjectors for the Emergency Treatment of Allergi

WARREN, N.J., Oct. 14, 2021 (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 third quarter ended September 30, 2021 and provide an update on recent developments in its business after market close on Tuesday, November 2, 2021.

Aquestive Therapeutics to Report Third Quarter 2021 Financial Results and Recent Business Highlights on November 2 and Host Conference Call on November 3 at 8:00 a.m. ET

WARREN, N.J., Oct. 06, 2021 (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 reached an agreement with its lenders providing for a bridge waiver of the first principal payment due under its 12.5% Senior Secured Notes (the “Notes”) in order to provide sufficient time for the parties to execute a definitive agreement to extend the time when the first principal payment is due under the Notes to March 30, 2023.

Aquestive Therapeutics Reaches Agreement to Extend Principal Payments Due Under Credit Facility to March 30, 2023 and Receives Bridge Waiver of Principal Debt Payment in Advance of Concluding Formal Agreement

WARREN, N.J., Aug. 06, 2021 (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 management team will participate in a panel entitled “Got My Mind Set On You - Advancing Novel Epilepsy Targets” at the 12th Annual Wedbush PacGrow Healthcare Virtual Conference to be held on Wednesday, August 11, 2021 at 11:30 am ET. The team will also host one-on-one investor meetings throughout the conference.

Aquestive Therapeutics to Participate in 12th Annual Wedbush PacGrow Healthcare Virtual Conference

Aquestive Therapeutics' (AQST) CEO Keith Kendall on Q2 2021 Results - Earnings Call Transcript

WARREN, N.J., Aug. 03, 2021 (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 reported financial results for the second quarter ended June 30, 2021 and provided an update on recent developments in its business.

Aquestive Therapeutics Reports Second Quarter 2021 Financial Results, Provides Business Update and Raises Full Year Revenue Guidance

Aquestive Therapeutics (AQST) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Aquestive Therapeutics (AQST) Q2 Earnings Expected to Decline

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WARREN, N.J., July 19, 2021 (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 accepted for filing the resubmission of the 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”) target goal date of December 23, 2021.

Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant™ (diazepam) Buccal Film

WARREN, N.J., June 24, 2021 (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 resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters in response to the September 25, 2020 Complete Response Letter (CRL) from the FDA. The submission included additional statistical modeling and supporting analyses of the existing clinical data based upon the guidance received from the Agency.

Aquestive Therapeutics Resubmits New Drug Application for Libervant™ (diazepam) Buccal Film

Aquestive Therapeutics is moving closer to resubmitting Libervant's NDA. The company expects to submit the NDA by the end of this month, which could put the PDUFA date in 2021. Aquestive continues to fight through COVID-19 headwinds and was able to report impressive Q1 numbers with SYMPAZAN recording strong year-over-year growth.

Aquestive Therapeutics: Bullish Outlook Continues To Harden

WARREN, N.J., June 21, 2021 (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 A. Ernest (Ernie) Toth, Jr., a seasoned financial executive and currently serving the Company as the interim Chief Financial Officer, has transitioned to the permanent role of Senior Vice President and Chief Financial Officer effective immediately.

Aquestive Therapeutics Announces Leadership Transition of Chief Financial Officer

WARREN, N.J., June 09, 2021 (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 management team will participate in two upcoming investor conferences in June.

Aquestive Therapeutics to Participate in JMP Securities and BMO Capital Market Investor Conferences

WARREN, N.J., May 11, 2021 (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 management team will participate in a fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference to be held virtually May 19, 2021 at 9:45 ET. Aquestive will also host one-on-one investor meetings throughout the conference.

Aquestive Therapeutics to Participate in 2021 RBC Capital Markets Global Healthcare Conference

Aquestive Therapeutics, Inc. (AQST) CEO Keith Kendall on Q1 2021 Results - Earnings Call Transcript

WARREN, N.J., May 04, 2021 (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 reported financial results for the first quarter ended March 31, 2021 and provided an update on recent developments in its business.

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