WAQRREN, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in two upcoming investor conferences in November and December 2024 as follows: Jefferies London... Read More

Anaphylm™ (epinephrine) Sublingual Film pre-NDA meeting scheduled for fourth quarter 2024 AQST-108 (epinephrine) Topical Gel pre-IND meeting scheduled for fourth quarter 2024 Libervant® (diazepam) Buccal Film for patients aged 2-5 available through retail distribution channels Finished third quarter 2024 with approximately $78 million of cash and reaffirms cash runway into 2026 To host investment community conference call at... Read More

Initial placement or subsequent movement of Anaphylm showed no impact on epinephrine pharmacokinetics (PK) or pharmacodynamics (PD), with all results comparable to epinephrine injection Data demonstrates Anaphylm offers a consistent and permissive method of drug delivery in anaphylaxis management WARREN, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a... Read More

Completed OAS challenge study meets both primary and secondary endpoints Demonstrates rapid resolution of allergen-related symptoms beginning two minutes after administration Pharmacokinetic (PK) profile after allergen exposure comparable to non-allergen PK profile On track for a pre-NDA meeting on Anaphylm in Q4 2024 WARREN, N.J., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a... Read More

WARREN, N.J., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the third quarter ended September 30, 2024 and provide an update on recent developments in its business... Read More

Announces completion of enrollment in its oral allergen challenge study for the development of its late-stage pipeline program, Anaphylm™ (epinephrine) Sublingual Film Outlines the development strategy for the Company’s next pipeline product candidate, AQST-108 (epinephrine) Topical Gel for the treatment of Alopecia areata Holds virtual investor day WARREN, N.J., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics,... Read More

WARREN, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced it will hold a virtual investor day on September 27, 2024 at 8:00 am ET to discuss the Company’s pipeline updates, inclusive of Anaphylm™... Read More

WARREN, N.J., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in two upcoming investor conferences in September 2024 as follows: H.C. Wainwright 26 th Annual... Read More

Applauds first FDA approval of non-injection-based epinephrine device Reiterates expected timing for filing of New Drug Application (NDA) for Anaphylm™ (epinephrine) Sublingual Film to the FDA in the first quarter of 2025 WARREN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to... Read More

Late-stage pipeline program, Anaphylm™ (epinephrine) Sublingual Film, remains on track for a near-term New Drug Application (NDA) submission to the FDA Expanded sales coverage for Libervant™ (diazepam) Buccal Film for patients between ages two to five with national retail distribution anticipated in the fourth quarter 2024 Anticipates holding epinephrine prodrug technology investor day in the coming months Finishes the... Read More

Meets primary study endpoints with pharmacokinetics (PK) comparable whether Anaphylm is administered by subjects or by healthcare providers (HCPs) Final supportive study, the Oral Allergy Syndrome (OAS) challenge study, currently enrolling Continues to anticipate requesting a pre-New Drug Application (NDA) meeting before the... Read More

WARREN, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the second quarter ended June 30, 2024 and provide an update on recent developments in its business after... Read More

WARREN, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the Aquestive management team will participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism and host investor... Read More

Anaphylm pharmacokinetic results unaffected by oral cavity exposure to liquids of different temperatures and pH Remains on track to complete Anaphylm supportive clinical studies and expects to request pre-NDA meeting with FDA in the third quarter 2024 Continues to anticipate filing a New Drug Application (NDA) shortly after completion of its pediatric study of Anaphylm WARREN, N.J., June 25, 2024 (GLOBE NEWSWIRE) --... Read More

WARREN, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced its expected addition to the broad-market Russell 3000 ® and Russell 2000 ® Indexes at the conclusion of the 2024 Russell U.S. indexes... Read More

Sherry Korczynski joins the leadership team as Senior Vice President, Sales and Marketing Dr. Stephen Wargacki promoted to Chief Science Officer Cassie Jung named Chief Operating Officer WARREN, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative... Read More

WARREN, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that two encore poster presentations highlighting the positive pharmacokinetic (PK) and pharmacodynamic (PD) data from two completed... Read More

WARREN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in The Citizens JMP Life Sciences Conference on May 13, 2024. The Aquestive management team will hold a fireside chat on May 13... Read More

Met all endpoints in Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film in first quarter 2024 when compared to EpiPen ® and other injectors used for the treatment of anaphylaxis On track to complete Anaphylm temperature/pH study in second quarter 2024 Received positive feedback from FDA on Anaphylm self-administration and allergen exposure protocols; remains on track to complete both studies in third quarter... Read More

Libervant is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients ages 2 to 5 Announces immediate availability of Libervant 5mg, 7.5mg, 10mg, 12.5mg, and 15mg for patients between 2 to 5 years of age Company track record now includes 4 FDA approvals since 2018 Anaphylm program on track; NDA submission expected by the end of 2024 Hosts conference call for... Read More

WARREN, N.J., April 25, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the first quarter ended March 31, 2024 and provide an update on recent developments in its business after... Read More

WARREN, N.J., April 12, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced a poster presentation highlighting the crossover study for the Company’s product candidate, Libervant™ (diazepam) Buccal Film for... Read More

WARREN, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the appointment of Abigail Jenkins to the Company’s Board of Directors, effective April 1, 2024. Ms. Jenkins has two decades of... Read More

WARREN, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced the closing of its previously announced underwritten public offering of 16,666,667 shares of its common stock at the public offering... Read More

WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc . (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share.... Read More

WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (Nasdaq: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Aquestive expects to grant... Read More

Anaphylm meets all predefined primary and secondary pharmacokinetic endpoints Anaphylm time to maximum concentration (Tmax) is consistently faster than autoinjectors Anaphylm exposure levels (AUC) are comparable to autoinjectors for 30 minutes after dosing Anaphylm is well-tolerated with no serious adverse events Company receives positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) regarding the... Read More

Reports full year 2023 revenue of $50.6 million and non-GAAP adjusted EBITDA loss of $11.6 million Reaffirms expected release of topline pivotal clinical data for Anaphylm™ (epinephrine) Sublingual Film in March 2024 Reaffirms anticipated FDA decision on Libervant™ (diazepam) Buccal Film application in April 2024 Provides full year 2024 financial guidance Hosts investment community conference call on March 6, 2024 WARREN,... Read More

WARREN, N.J., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the fourth quarter ended December 31, 2023 and provide an update on recent developments in its business... Read More

The clinical trial data show that epinephrine delivered via orally administered Anaphylm™ (epinephrine) Sublingual Film is comparable to epinephrine delivered via autoinjector or manual intramuscular (IM) injection. Anaphylm candidate, with the potential to be the first and only non-invasive, orally delivered epinephrine product, demonstrates clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q ® ) for... Read More

WARREN, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in the Oppenheimer 34 th Annual Healthcare Life Sciences Conference on February 13 th . The Aquestive team will hold a fireside... Read More

Commences initial Phase 3 study with first orally delivered epinephrine prodrug candidate Reaffirms topline data anticipated in first quarter 2024 WARREN, N.J., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today... Read More

WARREN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that two posters recapping the positive data from pharmacokinetic (PK) and pharmacodynamic (PD) pre-clinical and clinical studies of... Read More

Reiterates commencement of pivotal pharmacokinetic (PK) study for Anaphylm™ (epinephrine) Sublingual Film expected in fourth quarter 2023 with topline data targeted for first quarter 2024 Completes debt refinancing resulting in approximately $28 million of cash savings through June of 2025 Reported 25% year-over-year growth in year-to-date revenue adjusted for the out-license of Sympazan® Raises full year 2023 revenue... Read More

WARREN, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced the refinancing of its existing debt facility. The Company redeemed its 12.5% senior secured notes due 2025 (the “2019 Indenture”) and entered into a new financing... Read More

WARREN, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the third quarter ended September 30, 2023 and provide an update on recent developments in its business... Read More

Receives positive feedback from FDA on pivotal study protocol for Anaphylm™ (epinephrine) Sublingual Film Reaffirms fourth quarter 2023 Anaphylm pivotal Phase 3 study start and first quarter 2024 topline data readout Outlines expected remaining activities for Anaphylm program prior to NDA submission Indicates FDA review of Libervant™ (diazepam) Buccal Film NDA on track with no open questions Anticipates increasing 2023... Read More

WARREN, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided an update on the development timeline and pathway for its oral epinephrine product candidate, Anaphylm™. As previously disclosed, Aquestive submitted its... Read More

FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for treatment of seizure clusters in patients between two and five years of age Prescription Drug User Fee Act (PDUFA) target goal date set for April 28, 2024 WARREN, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current... Read More

WARREN, N.J., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, announced today that the management team will participate in two upcoming investor conferences in New York, NY as follows: H.C. Wainwright... Read More

Submitted proposed pivotal trial protocol for Anaphylm™ (epinephrine) Sublingual Film to the FDA Submitted an NDA to the FDA for Libervant™ (diazepam) Buccal Film for patients between two and five years of age Reported 24% year-over-year growth in quarterly revenue adjusted for the out-license of Sympazan® Raises full year 2023 revenue and improves non-GAAP adjusted EBITDA loss guidance To host investment community... Read More

WARREN, N.J., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, announced today that the management team will participate in the 2023 Wedbush PacGrow Healthcare Conference in New York. The Aquestive team... Read More

Reports positive topline data from latest pilot pharmacokinetic (PK) study Plans to submit pivotal PK clinical study protocol to the FDA in early August Anticipates commencement of its definitive pivotal PK clinical trial in the fourth quarter of 2023 WARREN, N.J., July 27, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc.... Read More

WARREN, N.J., July 25, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that it will report results for the second quarter ended June 30, 2023, and provide an update on recent developments in its... Read More

WARREN, N.J., July 25, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that two posters recapping the positive topline data from pharmacokinetic (PK) and pharmacodynamic (PD) studies of Anaphylm... Read More

WARREN, N.J., July 06, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that two posters recapping the positive data from pharmacokinetic and pharmacodynamic studies of Anaphylm epinephrine... Read More

Submitted NDA for Libervant™ (diazepam) Buccal Film for treatment of seizure clusters in patients between two and five years of age Appointed Carl N. Kraus, M.D. as Chief Medical Officer WARREN, N.J., June 29, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide... Read More

Time to maximum blood concentration (median Tmax) for Anaphylm was 10 minutes with a range of 5 to 20 minutes Early drug exposure at 10 minutes (partial area under the curve, or pAUC 0-10min ) for Anaphylm was similar to Auvi-Q® (epinephrine injection) auto-injector 0.3mg and over 4 times higher than epinephrine 0.3mg manual injection, while lower than both EpiPen® (epinephrine) auto-injector 0.3mg and the generic equivalent... Read More

Continues to advance development of AQST-109 (epinephrine sublingual film); received FDA conditional approval of brand name Anaphylm™ Raises full year 2023 revenue and non-GAAP adjusted EBITDA guidance Reaffirms commitment to pursue early market access for Libervant™ (diazepam) Buccal Film Obtains dismissal of outstanding shareholder lawsuits Generated $47 million non-dilutive cash in the last 12 months Hosts investment... Read More

WARREN, N.J., April 26, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, announced today that the management team will participate in two upcoming investor conferences as follows: The JMP Life Sciences Conference: fireside chat at 12:00 pm ET... Read More

WARREN, N.J., April 20, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Anaphylm™ as the proposed brand... Read More

WARREN, N.J., April 18, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that it will report results for first quarter ended March 31, 2023, and provide an update on recent developments in its... Read More

WARREN, N.J., March 29, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced it has expanded its exclusive license and supply agreement with Atnahs Pharma UK Limited (“Pharmanovia”), a global pharmaceutical company that revitalizes,... Read More

Pivotal study for AQST-109 (epinephrine sublingual film) on track to start in third quarter 2023 Financial turnaround actions on track including 18% reduction of outstanding debt and the receipt of $20 million of non-dilutive capital in the first quarter of 2023 Continues to engage FDA on next steps for Libervant™ (diazepam) Buccal Film Provides full year 2023 financial outlook Hosts investment community conference call on... Read More

WARREN, N.J., March 01, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, announced today that the management team will participate in the Oppenheimer 33 rd Annual Healthcare Conference from March 13 th to March 15 th . The Aquestive team is... Read More

WARREN, N.J., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that it will report results for fourth quarter ended December 31, 2022, and provide an update on recent developments in its... Read More

WARREN, N.J., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that four late breaking posters recapping the positive data from pharmacokinetic and pharmacodynamic studies of AQST-109... Read More

Anticipates commencing pivotal pharmacokinetic (PK) trial for AQST-109 (epinephrine sublingual film) in second half of 2023 Anticipates receipt in the coming months of FDA response to request for Libervant™ (diazepam) Buccal Film accelerated market access Expects preliminary unaudited cash and cash equivalents of approximately $27 million as of December 31, 2022 WARREN, N.J., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Aquestive... Read More

FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studies FDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance and patient administration attributes Company continues to anticipate a potential product launch in 2025 with an NDA submission in first half of 2024 WARREN, N.J., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc.... Read More