Newsroom

Press Releases

02.25.2021

Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission for Libervant™ (diazepam) Buccal Film Following FDA Feedback

02.17.2021

Aquestive Therapeutics to Announce Fourth Quarter and Year End 2020 Financial Results and Recent Business Highlights on March 9 and Host Conference Call on March 10 at 8:00 a.m. ET

02.09.2021

Aquestive Therapeutics Strengthens Board of Directors with Appointments of Julie Krop, M.D., and Marco Taglietti, M.D., and Announces Resignation of Douglas K. Bratton from Board of Directors

01.28.2021

Aquestive Therapeutics Appoints Mark Lepore, MD, as Chief Medical Officer for Allergy

01.21.2021

Mitsubishi Tanabe Pharma America and Aquestive Therapeutics Announce U.S. Licensing and Supply Deal for Riluzole Oral Film for ALS Treatment

01.07.2021

Aquestive Therapeutics Provides Business Update

01.04.2021

Aquestive Therapeutics to Present at Two Upcoming Investor Conferences

12.16.2020

Aquestive Therapeutics Announces Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer

11.25.2020

Aquestive Therapeutics to Present at Piper Sandler 32nd Annual Virtual Healthcare Conference

11.23.2020

Aquestive Therapeutics Receives First Milestone Payment from KYNMOBI™ Monetization

11.18.2020

Aquestive Therapeutics Completes FDA Type A Meeting on Libervant

11.04.2020

Aquestive Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

11.03.2020

Aquestive Therapeutics Signs Royalty Monetization Agreement with Marathon Asset Management for up to $125 Million

10.14.2020

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

09.25.2020

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

08.20.2020

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

08.10.2020

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

08.04.2020

Aquestive Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update: AQST-108 Progress Remains On Track; Libervant PDUFA Goal Date Approaches

07.28.2020

Aquestive Therapeutics to Present at 2020 Wedbush PacGrow Healthcare Virtual Conference

07.15.2020

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

06.29.2020

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

06.16.2020

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

06.04.2020

Aquestive Therapeutics to Hold Virtual-Only Annual Meeting of Stockholders

05.21.2020

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

05.07.2020

Aquestive Therapeutics to Present at 2020 RBC Capital Markets Global Healthcare Conference

05.05.2020

Aquestive Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update: AQST-108 and Libervant Remain On Track

04.21.2020

Aquestive Therapeutics to Announce First Quarter Financial Results and Recent Business Highlights on May 5 and Host Investment Community Conference Call on May 6

03.11.2020

Aquestive Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights

02.20.2020

Aquestive Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights on March 12, 2020

02.10.2020

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

02.06.2020

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

01.12.2020

Aquestive Therapeutics Receives FDA Response to Citizen’s Petition

01.10.2020

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

12.12.2019

Aquestive Therapeutics Announces Pricing of Public Offering of Common Stock

12.10.2019

Aquestive Therapeutics Announces Proposed Public Offering of Common Stock

12.04.2019

Aquestive Therapeutics to Host Investor & Analyst Libervant™ (diazepam) Buccal Film Update Forum at American Epilepsy Society 2019 Annual Meeting

12.02.2019

Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant™ (diazepam) Buccal Film for Management of Seizure Clusters

11.26.2019

Aquestive Therapeutics Announces Poster Presentations of Data on Libervant™ (diazepam) Buccal Film at American Epilepsy Society 2019 Annual Meeting

11.25.2019

Aquestive Therapeutics Receives FDA Approval for Exservan™ (riluzole) Oral Film

11.13.2019

Aquestive Therapeutics Licenses Riluzole Oral Film to Zambon for Development and Commercialization in the EU for Patients with ALS

Archives

April 2017

  • MonoSol Rx Appoints James S. Scibetta to Board of Directors

February 2017

  • MonoSol RX Receives FDA Acceptance Of New Drug Application For Tadalafil PharmFilm®

January 2017

  • John T. Maxwell Appointed CFO
  • Patent Infringement Suit Against BDSI
  • MonoSol Rx MonoSol Rx to Initiate Human Proof-of-Concept Study of Epinephrine Sublingual Soluble Film
  • MonoSol Rx Successfully Completes Dose Proportionality Study of Diazepam Buccal Soluble Film to Treat Acute Repetitive Seizures
  • MonoSol Rx Receives FDA Acceptance of Investigational New Drug Application for Riluzole Oral Soluble Film to Treat Amyotrophic Lateral Sclerosis

November 2016

  • MONOSOL RX RECEIVES FDA ORPHAN DRUG DESIGNATION FOR DIAZEPAM BUCCAL SOLUBLE FILM TO TREAT ACUTE REPETITIVE SEIZURES
  • MONOSOL RX SUBMITS NEW DRUG APPLICATION FOR TADALAFIL PHARMFILM®

September 2016

  • MonoSol Rx Responds to Civil Complaint Filed by States Attorneys General

August 2016

  • MonoSol Rx Closes $50 Million Credit Facility with Perceptive Advisors

June 2016

  • MonoSol Rx wins patent infringement suit against Par Pharmaceutical and Watson Pharmaceuticals related to Suboxone® Sublingual Film

April 2016

  • U.S. Patent and Trademark Office Upholds the Validity of MonoSol Rx’s US Patent No. 8,765,167 in the Face of Multiple Inter Partes Review Challenges Brought by BioDelivery Sciences International, Inc. (BDSI)
  • Cynapsus Therapeutics and MonoSol Rx Announce Global IP Licensing Agreement

March 2016

  • MonoSol Rx Successfully Completes Pre-IND Meeting with the FDA for PharmFilm® Tadalafil

January 2016

  • MonoSol Rx Appoints Santo J. Costa to Board of Directors

December 2015

  • MonoSol Rx Appoints Joanne M. Leonard as Chief Financial Officer

October 2015

  • MonoSol Rx to Present at 2015 American Association of Pharmaceutical Scientists Annual Exposition Demonstrating PharmFilm as a Bioequivalent Delivery Platform for Sildenafil Citrate
  • MonoSol Rx Leadership Presents Data Supporting PharmFilm Technology Effective for Oral Peptide Delivery

August 2015

  • MonoSol Rx Partner Galena Biopharma Launches Zuplenz® (ondanestron) Oral Soluble Film

July 2015

  • MonoSol Rx Announces Initiation of Phase 2a Trial for Oral Insulin Film

June 2015

  • Galena Biopharma Launches Zuplenz® (ondansetron) Oral Soluble Film

March 2015

  • Research Collaboration Signed with Global Pharmaceutical Company (via Midatech Pharma)

February 2015

  • MonoSol Rx Leadership Presented PharmFilm Buccal Delivery Clinical Update at Leading Pharmaceutical Technology Meeting

December 2014

  • MonoSol Rx names A. Mark Schobel Chief Innovation & Technology Officer; Keith Kendall assumes role of CEO

October 2014

  • US Patent Office Institutes Inter Partes Review Brought by MonoSol Rx Against All Claims in Key BDSI BEMA Patent

August 2014

  • MonoSol Rx Launches Clinical Study of MSRX-110 Oral Film for Testosterone Replacement

December 2012

  • MonoSol Rx Acquires U.S. Patent for Multifunctional Single Layer Film Drug Delivery Technology

October 2012

  • MonoSol Rx Defeats BDSI's Reexamination Challenges to MonoSol Rx's PharmFilm® Patents

September 2012

  • MonoSol Rx Developing Migraine Product for Treatment of Pain and Nausea in a Single Dose

May 2012

  • Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

February 2012

  • Monosol Rx, LLC Remains Confident in its Patent Portfolio

January 2012

  • MonoSol Rx and Midatech Launch MidaSol Therapeutics LP

November 2011

  • MonoSol Rx Announces Listing of Patent in FDA Orange Book for Suboxone® Sublingual Films
  • MonoSol Rx, LLC Remains Confident in its Patent Portfolio
  • MonoSol Rx and Midatech Ltd Receive Authorization to Conduct Phase I Human Trials for Transbuccal Insulin PharmFilm®

October 2011

  • MonoSol Rx, LLC Asserts Additional Patents to Infringement Lawsuit Against BioDelivery Sciences International, Inc.
  • MonoSol Rx Strengthens Canadian Patent Portfolio for PharmFilm®

August 2011

  • MonoSol Rx Announces Second PharmFilm® Product for ADHD

June 2011

  • MonoSol Rx Aligns Executive Leadership to Maximize Growth Opportunities, Operational Excellence and R&D Pipeline

April 2011

  • MonoSol Rx and KemPharm to Develop Novel PharmFilm® Product for ADHD

September 2010

  • Warren- based MonoSol Rx Introduces New Methods of Admnistering Medicine

August 2010

  • MonoSol Rx Announces Reckitt Benckiser FDA Approval of Suboxone Sublingual Film for Treatment of Opioid Dependence
  • Midatech and MonoSol Rx Announce Filing of Joint Patent Application for Nanoparticle File Delivery Systems

July 2010

  • MonoSol Rx Announces FDA Approval of ZuplenzB. Oral Soluble Film for Treatment of Nausea and Vomiting

June 2010

  • MonoSol Rx Expands Collarboration with Midatech to Deliver Peptides Utilizing its PharmFilmB. Drug Delivery Technology
  • MonoSol Rx Appoints Dr. Eric Dadey Senior Vice President, Pharmaceutical Development
  • MonoSol Rx Appoints Dr. Mary Ellen Norvitch Vice President of Regulatory Affairs, Clinical Affairs and Quality Assurance

July 2009

  • MonoSol Rx Appoints Theodore Clemente Vice President Business Development

June 2009

  • MonoSol Rx Announces FDA Acceptance of NDA for Ondansetron Orally Dissolving Film Strip

April 2009

  • MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
  • MonoSol Rx Granted U.S. Article of Manufacture Patent

March 2009

  • MonoSol Rx to Present at Cowen & Company 29th Annual Health Care Conference
  • MonoSol Rx Achieves Milestones for Additional $2.5 Million Private Debt Financing

December 2008

  • MonoSol Rx Enters Agreement with Hikma Pharmaceuticals PLC for Thin Film Pharmaceutical Products in the Middle East
  • MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA

November 2008

  • MonoSol Rx to Present at the 20th Annual Piper Jaffray Health Care Conference
  • MonoSol Rx and Midatech Group Enter Collaboration Agreement to Unite Nanoparticle and Thin Film Drug Delivery Technologies

September 2008

  • MonoSol Rx Closes $20 Million in Private Equity Financing
  • MonoSol Rx Granted Strategic US Patent for Thin Film Manufacturing Process

August 2008

  • MonoSol Rx Completes Thin Film Escitalopram Oxalate Pilot Bioequivalence Study

June 2008

  • MonoSol Rx Licenses Thin Film Formulation of Ondansetron to Strativa Pharmaceuticals, a Division of Par Pharmaceutical
  • MonoSol Rx Closes $10 Million in Private Debt Financing
  • MonoSol Rx Names Vincent Viviani Senior Vice President, Manufacturing and Operations

May 2008

  • MonoSol Rx Appoints John McCracken Senior Vice President Business Development

April 2008

  • MonoSol Rx, LLC granted US patent for thin film manufacturing process

February 2008

  • MonoSol Rx, LLC completes thin film ondansetron pilot bioequivalence study

April 2007

  • MonoSol Rx Announces Hiring of Larry W. Kranking as Senior Vice-President, Pharmaceutical Operations

December 2006

  • MonoSolRx Closes $38 Million Preferred Equity Investment

September 2006

  • MonoSolRx to Present at the UBS Global Life Sciences Conference

July 2006

  • MonoSolRx Announces Hiring of Keith Kendall as Chief Financial Officer
  • MonoSol Rx Completes Successful DEA Registration of Both Its Manufacturing Facility and Development Facility

June 2006

  • MonoSol Rx Completes Analytical Laboratories to Support Film Based Drug Development and Manufacturing

May 2006

  • MonoSol Rx Announces Legal Settlement With Novartis Consumer Health Relating

Events

December 2019

  • American Epilepsy Society Annual Meeting

    Location: Baltimore, MD
    Dates: December 6 - December 10, 2019
    Booths: #344 and #547

October 2019

  • Child Neurology Society Annual Meeting

    Location: Charlotte, NC
    Dates: October 23 - October 26, 2019
    Booths: #820 and #821

November 2018

  • American Epilepsy Society Annual Meeting

    Location:  New Orleans, LA
    Dates:  November 30 - December 4, 2018

  • CNS Summit

    Location:  Boca Raton, FL
    Dates:  November 1-4, 2018

October 2018

  • Child Neurology Society Annual Meeting

    Location:  Chicago, IL
    Dates:  October 15-18, 2018

September 2018

  • DDF Summit

    Location:  San Francisco, CA
    Dates:  September 10-11, 2018

  • BioPharm America

    Location:  Boston, MA
    Dates:  September 5-6, 2018

June 2018

  • BIO International Convention

    Location:  Boston, MA
    Dates:  June 4-7, 2018

April 2018

  • American Academy of Neurology Annual Meeting

    Location: Los Angeles, CA
    Dates: April 21-27, 2018

March 2018

  • American Association of Neuroscience Nurses Annual Education Meeting

    Location:  San Diego, CA
    Dates:  March 17-20, 2018

  • American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting

    Location:  Rockville, MD
    Dates:  March 7-10, 2018

February 2018

  • 2018 Epilepsy Foundation Pipeline Conference

    Location:  San Francisco, CA
    Dates:  February 22-23, 2018

January 2018

  • Drug Delivery Partnerships

    Location: Palm Beach Gardens, FL
    Dates: January 22-24, 2018

    Mark Schobel, Chief Innovation & Technology Officer, participated in a panel discussion titled “Oral Thin Films from Development to Commercialization”

  • JP Morgan Healthcare Conference

    Location: San Francisco, CA
    Dates: January 8-11, 2018

  • Biotech Showcase

    Location:  San Francisco, CA
    Dates: January 8-10, 2018

December 2017

  • 28th International Symposium on ALS/MND

    Location: Boston, MA
    Dates: December 8-10, 2017

  • American Epilepsy Society Annual Meeting

    Location: Washington, D.C.
    Dates: December 1-5, 2017

October 2017

  • BioNetwork West

    Location: Laguna Niguel, CA
    Dates: October 23–25, 2017

  • Partnerships in Drug Delivery

    Location: Boston, MA
    Dates: October 19–20, 2017

September 2017

  • BioPharm America

    Location: Boston, MA
    Dates: September 26–27, 2017

August 2017

  • Drug Delivery & Formulation Summit

    Location: Boston, MA
    Dates: August 28–29, 2017

Presentations

January 2021

  • Aquestive Corporate Presentation

December 2019

  • Safety and Tolerability Associated with Chronic Intermittent Use of Diazepam Buccal Film in Pediatric, Adolescent, and Adult Patients with Epilepsy
  • Simulation of the Pharmacokinetics of Diazepam Buccal Film in Adult Patients with Epilepsy with Weight-adjusted Dosing
  • Patient and Caregiver Preference for Route of Administration of a Benzodiazepine for Control of Increased Seizure Activity in Stable Patients
  • Unreliable Absorption with Rectal Administration of Diazepam
  • Pharmacokinetics of Diazepam Buccal Film in Adult Patients with Epilepsy: Comparison with Diazepam Rectal Gel

November 2018

  • The Usability of Diazepam Buccal Film as an Oral Rescue Treatment in Adult Patients with Epilepsy
  • Pharmacokinetics of Diazepam Buccal Film in Adult Patients with Epilepsy

April 2018

  • AAN Poster Presentations

March 2018

  • ASENT Poster Presentations

February 2018

  • 2018 Epilepsy Foundation Pipeline Conference Presentation

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Please complete this form:

  • To subscribe to receive marketing updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing clinicaltrials@aquestive.com.

Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

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