Aquestive Therapeutics, INC 8-K filings

Aquestive Therapeutics provides an update on its pipeline, including Anaphylm, Libervant, and AQST-108, along with financial guidance for 2024.

Aquestive Therapeutics reported its third quarter 2024 financial results, highlighted by advancements in its Anaphylm and Libervant programs, and reaffirmed its cash runway into 2026.

Aquestive Therapeutics announced that a subsequent analysis of its Anaphylm sublingual film demonstrated comparable pharmacokinetic and pharmacodynamic data to epinephrine injection, regardless of variable placement or intraoral movement.

Aquestive Therapeutics' Anaphylm sublingual film demonstrated positive topline results in an oral allergy syndrome challenge study, showing rapid symptom resolution and consistent pharmacokinetic profiles.

Aquestive Therapeutics has amended its bylaws, reducing the look-back period for stockholder nomination information from three to two years and making other technical updates.

Aquestive Therapeutics provided updates on its epinephrine product candidates, Anaphylm sublingual film and AQST-108 topical gel, at its virtual investor day.

Aquestive Therapeutics is advancing its pipeline, including Anaphylm for anaphylaxis, with a planned NDA submission in early 2025, and is also focused on the commercialization of Libervant for epilepsy.

Aquestive Therapeutics has commented on the recent FDA approval of a non-injection epinephrine device and reiterated its plan to file a New Drug Application (NDA) for its Anaphylm sublingual film in the first quarter of 2025.

Aquestive Therapeutics announced its second quarter 2024 financial results, highlighting progress in its Anaphylm and Libervant programs and a strengthened cash position.

Aquestive Therapeutics reports positive pharmacokinetic data from a self-administration study of Anaphylm, its sublingual epinephrine film for severe allergic reactions.

Aquestive Therapeutics held its 2024 Annual Meeting of Stockholders on June 20, 2024, where directors were elected, executive compensation was approved, and KPMG LLP was ratified as the independent auditor.

Aquestive Therapeutics highlights progress on its pipeline, including Anaphylm and Libervant, and provides a financial outlook for 2024.

Aquestive Therapeutics has promoted Cassie Jung to Chief Operating Officer, effective June 3, 2024.

Aquestive Therapeutics reports positive progress on its Anaphylm program, secures significant funding, and provides a 2024 financial outlook.

Aquestive Therapeutics announced positive first quarter 2024 financial results, highlighted by the successful completion of a Phase 3 study for Anaphylm and FDA approval for Libervant in younger pediatric patients.

Aquestive Therapeutics announced FDA approval for Libervant (diazepam) Buccal Film for treating seizure clusters in children aged 2 to 5 and provided an update on the Anaphylm (epinephrine) Sublingual Film development program.

Aquestive Therapeutics finalized its public offering, including the exercise of an over-allotment option, raising approximately $77.5 million in gross proceeds.

Aquestive Therapeutics has appointed Abigail L. Jenkins to its Board of Directors, effective April 1, 2024, increasing the board size to eight members.

Aquestive Therapeutics has launched a public offering of common stock to raise approximately $75 million for the development of its product pipeline and general corporate purposes.

Aquestive Therapeutics reports positive topline data from its Phase 3 study of Anaphylm, an epinephrine sublingual film, and successful completion of an FDA Type C meeting.

Aquestive Therapeutics announced its full year 2023 financial results, reporting $50.6 million in revenue and a non-GAAP adjusted EBITDA loss of $11.6 million, while also providing updates on key pipeline developments.