Aquestive Faces FDA Deficiencies on Anaphylm NDA Review

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

On January 9, 2026, Aquestive Therapeutics announced that the U.S. Food and Drug Administration has identified unspecified deficiencies in its New Drug Application for Anaphylm, a sublingual epinephrine film for severe allergic reactions, which currently prevents the agency from discussing labeling and post-marketing commitments and could delay a potential approval beyond the January 31, 2026 PDUFA date, although the FDA’s review remains ongoing and no final decision has been made. The company is engaging with the FDA to clarify and resolve the issues while pushing ahead with a global regulatory strategy for Anaphylm, including regulatory interactions in Canada, Europe and the U.K. in 2025 and planned approval submissions in 2026, and reported unaudited cash and cash equivalents of about $120 million as of December 31, 2025, which it believes is sufficient to fund U.S. approval and launch efforts and support its international expansion plans.

The most recent analyst rating on (AQST) stock is a Buy with a $11.00 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.

Aquestive Therapeutics’ overall stock score is primarily impacted by its weak financial performance, which poses significant risks. Positive technical indicators and recent corporate events provide some optimism, but ongoing financial challenges and valuation concerns limit the overall attractiveness.

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

More about Aquestive Therapeutics

Aquestive Therapeutics, Inc. is a pharmaceutical company that develops orally administered drugs using proprietary delivery technologies such as its PharmFilm® platform, offering alternatives to invasive and inconvenient standard-of-care therapies. The company manufactures four licensed commercialized products marketed by partners worldwide and is advancing a late-stage sublingual epinephrine film for severe allergic reactions, including anaphylaxis, along with an early-stage epinephrine prodrug topical gel for potential dermatological uses such as alopecia areata.

Average Trading Volume: 2,706,035

Technical Sentiment Signal: Buy

Current Market Cap: $760.1M

For detailed information about AQST stock, go to TipRanks’ Stock Analysis page.