Aquestive Therapeutics, INC 8-K filings

Aquestive Therapeutics announced positive topline results from human factors and pharmacokinetic studies for its Anaphylm sublingual film, supporting a planned New Drug Application resubmission to the FDA.

Aquestive Therapeutics, Inc. announced the results of its 2026 Annual Meeting of Stockholders, including the election of directors and the ratification of its independent auditor.

Aquestive reports a successful FDA Type A meeting for Anaphylm, aligns on study designs, and reaffirms an NDA resubmission target in Q3 2026.

Aquestive Therapeutics announced the appointment of Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer, succeeding Lori J. Braender, who will transition to Corporate Secretary.

Aquestive Therapeutics reported Q4 and full-year 2025 financial results, extended its revenue sharing agreement with RTW, and outlined a plan to address the FDA's Complete Response Letter for Anaphylm.

Aquestive Therapeutics received a Complete Response Letter for Anaphylm, delaying its approval, but plans a Q3 2026 resubmission backed by a strong cash position.

Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm, citing deficiencies in packaging and administration, but expects rapid resolution and Q3 2026 resubmission.

Aquestive Therapeutics announced FDA identified deficiencies in its Anaphylm NDA, potentially delaying approval, while confirming strong cash position and global expansion plans.

Aquestive Therapeutics provides a Q3 2025 update, highlighting Anaphylm's regulatory progress, pipeline expansion, and a strengthened balance sheet with $160 million in new financing.

Aquestive Therapeutics announced third quarter 2025 financial results, highlighted by Anaphylm's progress towards a January 2026 FDA decision and a strengthened balance sheet.

Aquestive Therapeutics announced the issuance of two new U.S. patents for its Anaphylm sublingual film, extending protection until at least 2037.

Aquestive Therapeutics strengthens its financial position with an $85 million equity raise and strategic funding, extending its cash runway into 2027 while advancing its lead product candidate Anaphylm towards a January 2026 PDUFA date.

Aquestive Therapeutics presented its strategic pipeline, including Anaphylm's PDUFA date and a recent $85 million equity raise, at the H.C. Wainwright 27th Annual Global Investor Conference.

Aquestive Therapeutics announced the FDA will not require an advisory committee meeting for its Anaphylm sublingual film, keeping its PDUFA date of January 31, 2026 on track.

Aquestive Therapeutics, Inc. priced an underwritten public offering of 21.25 million shares of common stock at $4.00 per share, expecting to raise $85 million in gross proceeds to fund Anaphylm commercialization and general corporate purposes.

Aquestive Therapeutics has secured a $75 million strategic funding agreement with RTW Investments LP to support the potential commercial launch of Anaphylm, contingent on FDA approval and debt refinancing.

Aquestive Therapeutics announced FDA acceptance of its Anaphylm NDA with a January 2026 PDUFA date, alongside a Q2 2025 net loss of $13.5 million and global expansion plans.

Aquestive Therapeutics, Inc. announced significant progress in its international regulatory strategy for Anaphylm (epinephrine) Sublingual Film, securing a meeting with Health Canada and submitting an initial briefing book to the European Medicines Agency.

Aquestive Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Anaphylm, an orally delivered epinephrine option for severe allergic reactions, setting a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026.

Aquestive Therapeutics, Inc. announced the successful election of two Class I directors, the approval of executive compensation, and the ratification of KPMG LLP as its independent auditor at its 2025 Annual Meeting of Stockholders.

Aquestive Therapeutics, Inc. has filed an 8-K to disclose its June 2025 investor presentation, highlighting significant progress in its pipeline, including the NDA submission for Anaphylm, and outlining substantial market opportunities for its key product candidates.

Aquestive Therapeutics reports its Q1 2025 financial results, highlights the NDA submission for Anaphylm, and provides a business update.

Aquestive Therapeutics reports positive results from its pediatric study of Anaphylm sublingual film and completes the NDA submission to the FDA, with potential NDA acceptance expected in Q2 2025.

Aquestive Therapeutics is progressing with its Anaphylm NDA submission, Libervant commercialization, and AQST-108 development, targeting significant market opportunities.

Aquestive Therapeutics announces progress on key pipeline products including Anaphylm NDA filing, AQST-108 Phase 2a trial, and Libervant commercialization, while reporting financial results for Q4 and full year 2024.

Aquestive Therapeutics will present new findings on its Anaphylm epinephrine sublingual film at the 2025 AAAAI Annual Meeting, showcasing its stability, potency, and effectiveness in treating severe allergic reactions.

Aquestive Therapeutics is on track to submit its Anaphylm NDA in Q1 2025 and begin a Phase 2a trial for AQST-108 in Q2 2025, with approximately $70 million in cash as of December 31, 2024.

Aquestive Therapeutics has been granted seven years of orphan drug exclusivity by the FDA for Libervant (diazepam) Buccal Film for treating seizure clusters in pediatric patients aged two to five.

Aquestive Therapeutics has received positive feedback from the FDA regarding its Anaphylm sublingual film and reaffirmed its plan to submit a New Drug Application (NDA) in the first quarter of 2025.

Aquestive Therapeutics announces the resignation of board member Santo J. Costa and subsequent changes to the Compensation Committee, effective November 4, 2024.