FDA Issues Complete Response Letter on Anaphylm Application

Aquestive Therapeutics ( (AQST) ) just unveiled an announcement.

On February 2, 2026, Aquestive Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter on January 30, 2026, for its New Drug Application for Anaphylm, a sublingual epinephrine prodrug film intended to treat Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more. The FDA’s concerns were limited to human factors and administration issues—such as difficulty opening the pouch and incorrect film placement—as well as the need for a single pharmacokinetics study related to packaging and labeling modifications, with no additional clinical trials, chemistry, manufacturing and controls, or core comparability data questioned. Aquestive has already modified Anaphylm’s packaging, instructions for use, and labeling, plans to conduct a new human factors validation study and the requested pharmacokinetics study in parallel, and targets a resubmission of the application as early as the third quarter of 2026, while emphasizing its strong cash position to fund U.S. approval and pre-launch activities. In parallel, the company is pushing ahead with its global strategy for Anaphylm, having begun regulatory engagement in Canada, Europe, and the U.K. in 2025; it expects to file for marketing authorization in Europe and submit a New Drug Submission in Canada in the second half of 2026, building on European Medicines Agency feedback that no further clinical trials are needed, a move that could strengthen its competitive position in non-invasive epinephrine treatments and broaden access to its allergy therapy in key international markets.

The most recent analyst rating on (AQST) stock is a Sell with a $3.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.

Spark’s Take on AQST Stock

According to Spark, TipRanks’ AI Analyst, AQST is a Neutral.

The score is held back primarily by weak financial performance (declining revenues, persistent losses, negative operating cash flow, and negative equity). Offsetting this somewhat are neutral-to-positive technicals and constructive earnings-call positioning around Anaphylm and extended funding runway, but the newly disclosed FDA deficiencies add near-term approval risk.

To see Spark’s full report on AQST stock, click here.

More about Aquestive Therapeutics

Aquestive Therapeutics is a U.S.-based pharmaceutical company that develops orally administered medicines using proprietary delivery technologies, such as its PharmFilm® platform, to provide non-invasive alternatives to standard-of-care therapies. The company has four licensed commercial products marketed by partners worldwide, serves as their exclusive manufacturer, and is advancing a late-stage epinephrine sublingual film for severe allergic reactions alongside an early-stage epinephrine prodrug topical gel for dermatological conditions.

Average Trading Volume: 3,937,809

Technical Sentiment Signal: Sell

Current Market Cap: $359.9M

See more insights into AQST stock on TipRanks’ Stock Analysis page.