FDA Accepts Aquestive’s New Drug Application for Anaphylm

Aquestive Therapeutics ( (AQST) ) has issued an announcement.

On June 16, 2025, Aquestive Therapeutics announced that the FDA accepted its New Drug Application for Anaphylm™, an orally delivered epinephrine for treating severe allergic reactions, with a PDUFA target action date set for January 31, 2026. If approved, Anaphylm would be the first oral epinephrine option in the U.S., potentially transforming anaphylaxis care by addressing barriers such as fear of administration and the inconvenience of carrying bulky devices.

The most recent analyst rating on (AQST) stock is a Buy with a $9.00 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 currently faces significant financial and operational challenges. The most critical risk factors include declining revenues, negative profit margins, and high leverage. While technical indicators show potential short-term momentum, valuation metrics and corporate events reveal underlying financial difficulties that hinder long-term prospects.

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

More about Aquestive Therapeutics

Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies. The company develops orally administered products to provide novel alternatives to invasive therapies and has several commercialized products marketed globally by its licensees.

Average Trading Volume: 1,507,170

Technical Sentiment Signal: Buy

Current Market Cap: $339.7M

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