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 specialty pharmaceutical innovator developing non-invasive therapies for central nervous system disorders and severe allergic reactions. This page serves as the definitive source for official company announcements, regulatory updates, and strategic developments.
Investors and industry stakeholders will find timely updates on product approvals, clinical trial milestones, licensing agreements, and financial performance. Our curated feed includes press releases related to Aquestive’s proprietary PharmFilm® technology, partnership expansions, and advancements in treatments like anaphylaxis management solutions.
All content is organized to provide clear insights into the company’s progress in addressing complex medical needs through innovative drug delivery systems. Key areas of coverage include FDA communications, research breakthroughs, and market expansion initiatives that underscore Aquestive’s role in reshaping patient care paradigms.
Bookmark this page for direct access to primary-source information about AQST’s scientific advancements and corporate strategy. Check regularly for updates that matter to your analysis of this pioneering healthcare company.
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.
Aquestive Therapeutics (NASDAQ: AQST) announced the USPTO issued two new U.S. composition patents for Anaphylm (dibutepinephrine) Sublingual Film, extending patent protection through at least May 4, 2037. The patents (U.S. 12,427,121 and U.S. 12,443,850) cover epinephrine prodrug formulations and film-based oral mucosal absorption enabled by the company's PharmFilm and Adrenaverse technologies.
Anaphylm is positioned as a device-free, oral sublingual alternative to injectable epinephrine for severe allergic reactions. The FDA PDUFA target action date for Anaphylm is January 31, 2026. Each patent expiration is subject to any applicable extensions.
Aquestive Therapeutics (NASDAQ: AQST) announced that the FDA will not require an advisory committee meeting for its New Drug Application (NDA) for Anaphylm™, their sublingual epinephrine film for treating severe allergic reactions. The PDUFA target date remains January 31, 2026.
Anaphylm, if approved, would be the first FDA-approved non-invasive, orally delivered epinephrine product for anaphylaxis treatment. The product, similar in size to a postage stamp, is administered as a dissolvable film under the tongue. Clinical development included 11 studies with 967 total administrations across adults and children over 30 kg.
Following recent $160 million in financing, the company is positioned for commercial launch pending FDA approval.
Aquestive Therapeutics (NASDAQ:AQST) has announced its management team's participation in three major healthcare investor conferences in September 2025:
- Cantor Healthcare Conference: Fireside chat on September 4th at 8:00 AM ET with investor meetings on September 3rd-4th
- Wells Fargo Healthcare Conference: Investor meetings on September 5th
- H.C. Wainwright Global Investor Conference: Presentation on September 9th at 10:00 AM ET with investor meetings on September 8th-9th
Webcasts for the Cantor and H.C. Wainwright events will be available on the company's investor relations website with 30-day replay access.
Aquestive Therapeutics (NASDAQ: AQST) has announced the pricing of an underwritten public offering of 21,250,000 shares of common stock at $4.00 per share, expected to raise gross proceeds of $85 million.
The offering, led by RTW Investments with participation from notable investors including Samsara BioCapital and EcoR1 Capital, is expected to close around August 15, 2025. The proceeds will primarily fund the launch and commercialization of Anaphylm™ Sublingual Film for severe allergic reactions, pending FDA approval.
Leerink Partners, Cantor, and Oppenheimer & Co. are serving as joint bookrunning managers, with H.C. Wainwright as lead manager and Brookline Capital Markets as co-manager for the offering.
Aquestive Therapeutics (NASDAQ: AQST) has secured a $75 million strategic funding agreement with RTW Investments to support the potential launch of Anaphylm™, a sublingual film for emergency treatment of allergic reactions. The funding is contingent on FDA approval and other conditions.
The financing will strengthen Aquestive's balance sheet through 2027 and support the commercialization of Anaphylm, potentially the first oral rescue medication for severe allergic reactions. Under the agreement, RTW will receive a tiered single-digit percentage of annual U.S. net sales, subject to a cap.
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