Aquestive Therapeutics

AQST

시가총액 US$4.74억

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.

SAN FRANCISCO, Oct. 7, 2026 /PRNewswire/ -- Schubert Jonckheer & Kolbe LLP advises Aquestive Therapeutics, Inc. (Nasdaq: AQST) investors that the firm is investigating potential legal claims arising from alleged false and misleading statements about the company's drug candidate Anaphylm. Current shareholders are encouraged to contact the firm here: https://www.classactionlawyers.com/aquestive.

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.

WARREN, N.J., Sept. 01, 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, announced today that the management team will participate in four upcoming investor conferences in September 2026 as follows:

Aquestive Therapeutics, Inc. (AQST) Q2 2026 Earnings Call Transcript

Aquestive Therapeutics NASDAQ: AQST said it plans to resubmit its new drug application for Anaphylm, its epinephrine sublingual film candidate for type 1 allergic reactions including anaphylaxis, before the end of the third quarter after completing studies requested by the U.S. Food and Drug Administration.

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.1. This compares to a loss of $0.14 per share a year ago.

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.