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. develops and manufactures specialty pharmaceutical products using proprietary oral-film and drug-delivery technologies. News about AQST centers on the company’s proprietary pipeline, including Anaphylm™ (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, and AQST-108, an epinephrine prodrug topical gel being explored for dermatological conditions such as alopecia areata.
Recurring updates also cover FDA interactions and NDA communications for Anaphylm, pharmacokinetic and human-factor study topics, quarterly financial results, licensee and CDMO manufacturing activity, investor presentations, equity inducement grants, and legal, compliance, and board-governance changes.
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.
Aquestive Therapeutics (NASDAQ: AQST) reported third-quarter 2025 results and a business update on Nov 5, 2025. Key points: Anaphylm NDA remains on track for a Jan 31, 2026 PDUFA date with the FDA declining an Advisory Committee; a U.S. launch is planned for Q1 2026 if approved. The company expanded Anaphylm patent protection into 2037 and is advancing regulatory engagement in Canada and the EU. AQST is progressing AQST-108 with an IND planned in Q4 2025 and a study expected H1 2026. Q3 2025 revenue was $12.8M, manufacturing revenue rose to $11.5M, net loss was $15.4M (loss per share $0.14), non-GAAP adjusted EBITDA loss was $8.6M, and cash was $129.1M. 2025 guidance: $44–$50M revenue, non-GAAP EBITDA loss $47–$51M.
Aquestive Therapeutics (NASDAQ: AQST) announced leadership changes to support the planned launch of Anaphylm™ (dibutepinephrine) Sublingual Film, if approved by the FDA, and to accelerate its clinical pipeline. Matthew Davis, M.D., RPh joins immediately as Chief Development Officer. Gary Slatko, M.D., M.B.A. becomes interim Chief Medical Officer and Peter Boyd, M.B.A. is promoted to Chief People Officer.
The company disclosed an inducement equity grant for Dr. Davis: 50,000 RSUs and 50,000 options to be granted on the second trading day after the next public quarterly or annual results, vesting 25% at years one and two and 50% at year three; options have a 10-year term and an exercise price equal to the closing price on Nov 10, 2025.
Aquestive Therapeutics (NASDAQ: AQST) announced a live fireside chat hosted by Piper Sandler on November 6, 2025 at 12:00 p.m. ET. The session will feature Aquestive management—Dan Barber (CEO), Ernie Toth (CFO) and Sherry Korczynski (Chief Commercial Officer)—and focus on the product candidate Anaphylm (dibutepinephrine) Sublingual Film, covering regulatory progress and commercial readiness. Registration is through Piper Sandler representatives. A replay will be available for 30 days after the event on the company’s Investors "Events and Presentations" webpage at investors.aquestive.com.
Aquestive Therapeutics (NASDAQ: AQST) will present multiple abstracts on its investigational Anaphylm™ (dibutepinephrine) sublingual film at the 2025 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting in Orlando, FL, November 6–10, 2025.
An oral presentation on Nov. 9, 2025 will cover Phase 1 pharmacokinetics, pharmacodynamics, safety and tolerability in at‑risk pediatric patients (presenter: Matthew Greenhawt, MD). Two posters led by Nils F. Confer, PhD, will present PK data and survey insights on Nov. 7 and Nov. 9. Abstracts will be posted online and on the company Scientific Events page beginning Nov. 6, 2025.
Aquestive Therapeutics (NASDAQ: AQST) will report third quarter results for the period ended September 30, 2025 after market close on Wednesday, November 5, 2025. Management will host a conference call for investors at 8:00 a.m. ET on Thursday, November 6, 2025. Investors must register in advance to obtain a local or toll-free number and personal pin. A live webcast will be available on the company’s Investors website and a replay will be archived for 30 days at https://investors.aquestive.com/events-and-presentations.