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) reported third-quarter 2026 revenue of $7.6 million, down 41% from the same period a year earlier. Net loss widened to $16.5 million from $15.4 million, while basic and diluted loss per share narrowed to $0.13 from $0.14. Cash and cash equivalents were $90.3 million at September 30.
The FDA accepted the Anaphylm resubmission as a complete Class 2 response, setting a March 16, 2027 review goal date. Aquestive expects a Canadian submission in Q4 2026 and plans an EU filing in Q1 2027. In October, it granted Eton exclusive U.S. Libervant commercialization rights for $10 million upfront, potential milestones and royalties, retaining exclusive manufacturing under a 20-year agreement. Full-year guidance remains unchanged at $46–$50 million revenue and a non-GAAP adjusted EBITDA loss of $35 million to $30 million.
Aquestive Therapeutics (NASDAQ: AQST) will report third-quarter 2026 financial results after market close on November 3, 2026. The results cover the quarter ended September 30, 2026, and will accompany an update on recent business developments. Management will host an investor conference call on November 4, 2026, at 8:00 a.m. ET.
Aquestive Therapeutics (AQST) announced FDA acceptance of its Anaphylm application resubmission as complete, with a March 16, 2027 goal action date. The FDA classified the resubmission as a Class 2 response. Anaphylm is a dibutepinephrine film placed under the tongue, proposed for treating Type I allergic reactions, including anaphylaxis.
The September 16, 2026 resubmission followed August announcements of positive topline results from human factors and pharmacokinetic studies, which assess use and drug movement through the body. Those studies addressed items raised in the FDA’s January 30, 2026 Complete Response Letter. Aquestive is advancing commercial preparations for a potential launch if approved and says its planned submission to Health Canada remains on track for Q4 2026.
Eton Pharmaceuticals (ETON) entered exclusive U.S. licensing and supply agreements with Aquestive Therapeutics (AQST) for LIBERVANT, a seizure-cluster treatment.
The agreements cover the United States and its territories. Eton anticipates commercial availability in April 2027, subject to final FDA approval, and plans a dedicated neurology team. LIBERVANT, a diazepam film placed inside the cheek, has tentative approval for patients with epilepsy ages 2 to 5 and 12 and above. Full approval for ages 12 and above is expected to become possible after VALTOCO’s orphan drug exclusivity expires on January 10, 2027.
An application to add ages 6 to 11 is under FDA review, with a March 29, 2027 target action date; approval would expand the potential label to ages 6 and older. LIBERVANT has Orphan Drug Designation and issued patent protection extending into 2038, with additional patent applications pending.
Aquestive Therapeutics (AQST) appointed Rich Daly to its board of directors, effective October 14, 2026.
Daly has more than 30 years of biopharmaceutical leadership experience, focused on commercial and operating roles. Following his appointment, the board will have eight directors, seven of whom the board has determined are independent under applicable Nasdaq standards.
Aquestive Therapeutics (AQST) has resubmitted its New Drug Application to the FDA for Anaphylm (dibutepinephrine) sublingual film to treat Type I allergic reactions, including anaphylaxis.
The resubmission is supported by positive topline human factors and pharmacokinetic studies completed in response to the FDA’s January 30, 2026 Complete Response Letter. The human factors work evaluated revised packaging and instructions for use, reducing median pouch‑opening time from 17 seconds to 3 seconds. A confirmatory PK study in healthy volunteers using the revised packaging assessed both self‑administration and clinician administration, with manual intramuscular epinephrine as a comparator, and reported no protocol‑defined use errors in the self‑administration arm.
Clinical data cited by the company indicate rapid onset with robust heart rate and blood pressure responses that were comparable to or greater than auto‑injectors and manual IM epinephrine. The FDA will determine the resubmission classification and review timeline after its initial review.
Aquestive Therapeutics (NASDAQ:AQST) announced that its management team will participate in four investor conferences in September 2026: the Wells Fargo Healthcare Conference on September 8, the Cantor Healthcare Conference on September 9, Citi’s 2026 Biopharma Back to School Summit on September 10, and the H.C. Wainwright 27th Annual Global Investor Conference on September 14-15.
According to Aquestive, webcasts of the Cantor fireside chat and the H.C. Wainwright presentation, along with 30-day replays, will be available on the Investors "Events and Presentation" section of the company’s website.
Aquestive Therapeutics (NASDAQ: AQST) reported second quarter 2026 revenue of $13.8 million, up 38% from $10.0 million, driven mainly by higher manufacture and supply revenue and increased license and royalty income. Non-GAAP adjusted EBITDA loss improved to $5.2 million from $9.3 million. Net loss was $22.9 million (or $11.2 million excluding an $11.7 million one-time loss on extinguishment of 13.5% Notes), versus a $13.5 million loss a year ago. Cash and cash equivalents were $98.5 million at June 30, 2026.
The company completed the human factors validation and pharmacokinetic studies required for Anaphylm and remains on track to resubmit the NDA in Q3 2026, while advancing ex-U.S. regulatory plans and commercial readiness. AQST-108 development progressed with a completed Phase 1 study and expansion into additional dermatologic indications. Full-year 2026 revenue guidance of $46–$50 million and non-GAAP adjusted EBITDA loss of $35–$30 million was reaffirmed.
Aquestive Therapeutics (NASDAQ: AQST) reported positive topline results from a human factors validation study and a pharmacokinetic (PK) study of Anaphylm sublingual film, supporting a planned NDA resubmission in the third quarter of 2026 for Type 1 allergic reactions, including anaphylaxis.
The revised packaging cut median pouch-opening time from 17 to 3 seconds, reduced users with opening difficulty from 26/166 to 1/105, and lowered incorrect film placement from 20/166 to 2/105, with no chewing or film removal observed. In the PK study, self-administered Anaphylm achieved a geometric mean Cmax of 391.7 pg/mL and median Tmax of 12 minutes, similar to clinician-administered dosing and higher, faster exposure than manual intramuscular epinephrine. Incorrect top-of-tongue placement still produced Cmax above 100 pg/mL, a 35-minute Tmax, and clinically meaningful pharmacodynamic effects comparable to or exceeding injectable epinephrine, with no serious adverse events or discontinuations reported.
Aquestive Therapeutics (NASDAQ:AQST) will report its second quarter 2026 financial results and recent business highlights after market close on Tuesday, August 11, 2026. Management will host an investor conference call at 8:00 a.m. ET on Wednesday, August 12, 2026, with live webcast and a 30-day online replay on the company’s investor relations website.