Welcome to our dedicated page for Aquestive Therapeutics news (Ticker: AQST), a resource for investors and traders seeking the latest updates and insights on Aquestive Therapeutics stock.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company that frequently reports on the progress of its proprietary drug delivery technologies and product candidates. Company news often centers on Anaphylm™ (dibutepinephrine) Sublingual Film, a polymer matrix-based epinephrine prodrug product candidate in late-stage development for severe allergic reactions, including anaphylaxis. Press releases describe clinical data, regulatory milestones, and interactions with the U.S. Food and Drug Administration (FDA) and other regulators.
Investors following AQST news can expect updates on the FDA review of the Anaphylm New Drug Application, including communications about advisory committee decisions, review status, and identified deficiencies, as well as the company’s efforts to address regulatory feedback. Aquestive also issues news about its global regulatory strategy for Anaphylm, such as planned and ongoing submissions in Canada, Europe, and the United Kingdom, and feedback from agencies like Health Canada and the European Medicines Agency.
Beyond Anaphylm, Aquestive’s news flow includes developments in its AdrenaVerse™ epinephrine prodrug platform and the AQST‑108 topical gel program for dermatologic conditions, including alopecia areata. The company regularly reports quarterly financial results, outlines its outlook, and discusses manufacturing and royalty-based revenues from licensed products such as Suboxone® Sublingual Film, Sympazan® Oral Film, Ondif® Oral Film, and Azstarys®.
Additional AQST news items cover patent issuances for Anaphylm and related technologies, leadership changes intended to support clinical and commercial execution, participation in healthcare and investor conferences, and financing transactions linked to future product revenues. Readers interested in AQST news can use this page to monitor regulatory, clinical, financial, and strategic announcements that shape the company’s trajectory.
Aquestive Therapeutics (NASDAQ: AQST) granted inducement equity awards to Matthew Greenhawt, its newly hired Chief Medical Officer, under the 2022 Equity Inducement Plan. The awards total 75,000 RSUs and 50,000 non‑qualified stock options to be granted on March 9, 2026.
The awards vest 25% after each of the first and second anniversaries and 50% on the third anniversary, the options have a ten‑year term and an exercise price equal to the March 9, 2026 closing price. Awards rely on Nasdaq Listing Rule 5635(c)(4) and were approved by the independent Compensation Committee.
Aquestive Therapeutics (NASDAQ: AQST) reported Q4 and full‑year 2025 results and a business update on March 4, 2026. Q4 revenue rose 10% to $13.0M driven by manufacture and supply; the company manufactured ~47M doses in Q4. Management received an FDA Complete Response Letter for Anaphylm and plans a Type A meeting and NDA resubmission in Q3 2026. Aquestive guides to ~$70M cash at year‑end FY2026 and closed amendments with RTW including a $5.0M minimum share purchase commitment.
Aquestive Therapeutics (NASDAQ:AQST) said its management team will attend four investor conferences in March, including TD Cowen, Leerink Partners, Citizens Life Sciences, and Barclays.
Presentations, a Leerink fireside chat, and 1x1 meetings are scheduled; webcasts and 30-day replays will be posted on the company's Investors "Events and Presentation" page.
Aquestive Therapeutics (NASDAQ: AQST) will report fourth-quarter 2025 financial results after market close on Wednesday, March 4, 2026, and will provide recent business updates.
Management will host a conference call for investors on March 5, 2026 at 8:00 a.m. ET with a live webcast and a 30-day replay available on the company investor website.
Aquestive Therapeutics (NASDAQ: AQST) will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, a virtual event on February 25-26, 2026. Management will present on February 26 at 12:00 PM ET and will hold investor one-on-ones the same day.
A webcast will be available on the company’s Investors "Events and Presentations" page, with a replay accessible for 30 days following the presentation.
Aquestive Therapeutics (NASDAQ: AQST) will present new clinical data on Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting, Feb 27–Mar 2, 2026, in Philadelphia.
Posters report that Anaphylm achieved clinically relevant epinephrine plasma concentrations and showed no diastolic blood pressure dip after sublingual dosing; presentations are scheduled for March 1, 9:45–10:45 AM (Posters 610 and 611).
Aquestive Therapeutics (NASDAQ: AQST) named Dr. Matthew Greenhawt as Chief Medical Officer on Feb 18, 2026, to support the planned resubmission of the Anaphylm (dibutepinephrine) NDA and advance the company’s clinical pipeline. Dr. Greenhawt is a board‑certified allergist with extensive research, advocacy, and editorial experience and received the 2026 Distinguished Clinician Award.
The appointment follows interim CMO Gary Slatko remaining on the medical team to support the NDA resubmission and potential launch if FDA approval is granted.
Aquestive Therapeutics (NASDAQ: AQST) announced the FDA issued a Complete Response Letter for Anaphylm (dibutepinephrine) on Jan 30, 2026, citing human factors and a supportive PK study requirement.
The company says the CRL is confined to packaging/administration, plans a modified pouch/instructions, a new HF validation and PK study, and estimates resubmission in Q3 2026. No CMC issues were noted. Aquestive expects EU and Canada filings in H2 2026 and says it remains well-capitalized to complete approval and pre-launch activities.
Aquestive Therapeutics (NASDAQ: AQST) said the FDA identified deficiencies in the Anaphylm (dibutepinephrine) NDA that currently preclude labeling discussions, while confirming the agency's review remains ongoing and no final decision has been made. The company said a Discipline Review Letter will not be issued but information requests are possible and delays in communicating deficiencies could delay approval before the PDUFA action date of Jan 31, 2026. The Anaphylm program includes 11 studies with ~967 administrations across 411 subjects. Aquestive reported ~$120 million cash as of Dec 31, 2025 and plans regulatory submissions in Canada, Europe, and the UK in 2026.
Aquestive Therapeutics (NASDAQ:AQST) announced that management will participate in the Piper Sandler 37th Annual Healthcare Conference in New York City, December 2-4, 2025.
The company will hold a fireside chat on December 4, 2025 at 10:00 a.m. ET with Piper Sandler Sr. Research Analyst David Amsellem to discuss the product candidate Anaphylm (dibutepinephrine) sublingual film, including regulatory progress and commercial readiness. Management will host investor meetings the same day.
A live webcast of the fireside chat will be available on the company’s Investors > Events and Presentations page, with a replay accessible for 30 days following the event.