Aquestive Therapeutics, Inc. Stock News

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 expec...

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 Appli...

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 bri...

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 phar...

WARREN, N.J., Aug. 11, 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 financial results for the second quarter ended June 30, 2026, and provided a strategic business update.

Human factors and clinical study results support planned resubmission of Anaphylm™ NDA in the third quarter of 2026 Self-administration pharmacokinetic (PK) results were comparable to clinician-administered PK results Revised packaging design reduced median time to open pouch from 17 seconds in the previous human factors study to 3 seconds Revised instructions for use reduced incorrect film pla...