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 (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.
Aquestive Therapeutics (NASDAQ:AQST) will participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 14, 2026. Management will also host 1x1 investor meetings.
The forum will feature panels on immunology and inflammation (I&I) and metabolism, areas relevant to therapeutic innovation.
Aquestive Therapeutics (NASDAQ:AQST) reported Q1 2026 revenue of $14.4 million, up 66% year over year, and a net loss of $8.1 million versus $22.9 million in Q1 2025. Non-GAAP adjusted EBITDA loss was $1.7 million.
The company reaffirmed plans to resubmit the Anaphylm NDA in Q3 2026, advanced ex-US regulatory work, completed a phase 1 study of AQST-108, and entered a new $150 million debt facility with Oaktree, expecting $150 million in launch liquidity if Anaphylm is approved in 2027.
Aquestive Therapeutics (NASDAQ:AQST) refinanced its existing debt with a new $150 million five-year facility from Oaktree Capital Management. The deal funds repayment of a $45 million loan and offers interest-only payments with principal due at maturity.
The facility includes an initial $55 million funded at closing, $20 million upon FDA approval of Anaphylm and other conditions, a $25 million sales milestone tranche, and up to $50 million subject to mutual consent, enhancing flexibility for a potential Anaphylm launch and meeting conditions under a strategic funding agreement with RTW Investments.
Aquestive Therapeutics (NASDAQ: AQST) will report first quarter 2026 financial results for the period ended March 31, 2026 after market close on Wednesday, May 13, 2026, and will host a conference call at 8:00 a.m. ET on May 14, 2026.
A live webcast will be available in the Investors section of Aquestive's website, and a replay will be archived for 30 days.
Aquestive Therapeutics (NASDAQ: AQST) completed a Type A meeting with the FDA on March 30, 2026, for Anaphylm (dibutepinephrine) sublingual film. The company received clarifying FDA feedback on PK and human factors (HF) study designs, will address comments, and reaffirms an NDA resubmission planned for Q3 2026. Final FDA meeting minutes are expected by early May 2026. FDA acknowledged container closure revisions and aligned on labeling language to address potential chewing of the film. Aquestive is also advancing regulatory filings in Canada and the EU.