AQST

WARREN, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a biopharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science, today announced that multiple oral and poster presentations will be featured at the 2026 American College of Allergy, Asthma, and Immunology (ACAAI) Annual Meeting, taking place November 12-16, 2026, in Phoenix, Arizona.

Aquestive Therapeutics, Inc. ( AQST ) Q3 2026 Earnings Call November 4, 2026 8:00 AM EST Company Participants Faith Pomeroy-Ward Daniel Barber - CEO, President & Director Ernie Toth - Senior VP & CFO Sherry Korczynski - Chief Commercial Officer Melina Cioffi - Senior Vice President of Regulatory Affairs Matthew Greenhawt - Chief Medical Officer Conference Call Participants Roanna Clarissa Ruiz - Leerink Partners LLC, Research Division Kristen Kluska - Cantor Fitzgerald & Co., Research Division David Amsellem - Piper Sandler & Co., Research Division François Brisebois - LifeSci Capital, LLC, Research Division Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division Thomas Flaten - Lake Street Capital Markets, LLC, Research Division Presentation Operator Good day, and thank you for standing by.

Aquestive Therapeutics NASDAQ: AQST said it resubmitted its application for Anaphylm, an epinephrine sublingual film intended for severe allergic reactions, before the end of the third quarter and is preparing for a potential U.S. launch next year if the product receives Food and Drug Administration approval.

Anaphylm resubmission accepted with PDUFA goal date of March 16, 2027 Anaphylm would be the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis, if approved Commercial preparations remain on track to support a potential U.S. launch of Anaphylm following FDA approval Ex-U.S. Anaphylm strategy progressing, with Health Canada submission expected in Q4 2026 and an EU filing planned for Q1 2027 Company to host investor call on November 4, 2026, at 8:00 a.m. ET WARREN, N.J.

Four pharmaceutical and biotech stocks are seeing unusual options activity today, with Inovio Pharmaceuticals Inc (NASDAQ:INO), Aquestive Therapeutics Inc (NASDAQ:AQST), X4 Pharmaceuticals Inc (NASDAQ:XFOR), and Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) all drawing elevated volume.

WARREN, N.J., Oct. 27, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a biopharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report financial results for the third quarter ended September 30, 2026, and provide an update on recent developments in its business after market close on Tuesday, November 3, 2026.

Aquestive Therapeutics received FDA acceptance for the Anaphylm NDA resubmission, targeting a March 16, 2027 PDUFA date. Resubmission addresses prior FDA concerns with improved human factors data, showing a significant reduction in packaging and administration errors. I upgrade AQST to Buy, anticipating Anaphylm approval and potential >$250m annual revenue by 2030, despite competitive and reimbursement risks.

WARREN, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a biopharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, in keeping with the FDA's classification of the resubmission as a Class 2 response. If approved, Anaphylm would be the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis.

Appoints Rich Daly, a life sciences executive with more than 30 years of leadership experience across large pharmaceutical companies, emerging biotechnology companies, and public company boards, to its Board of Directors WARREN, N.J., Sept. 29, 2026 (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 Rich Daly to the Company's Board of Directors, effective October 14, 2026.

Resubmission supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026 FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission WARREN, N.J., Sept. 17, 2026 (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 has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis.