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FMP

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Maintains "Outperform" Rating Amid FDA Setback

Aquestive Therapeutics, Inc. (NASDAQ:AQST) is a pharmaceutical company focused on developing and commercializing innovative products to address unmet medical needs. The company specializes in oral film-based drug delivery systems. As of February 2, 2026, Oppenheimer has maintained its "Outperform" rating for AQST, with the stock price at $4.25.

Recently, Aquestive received a Complete Response Letter (CRL) from the FDA regarding its Anaphylm Epinephrine Sublingual Film. This drug is designed to treat severe allergic reactions in patients weighing 30 kilograms or more. The FDA's decision, announced on January 30, 2026, cited deficiencies related to packaging and administration.

Despite this setback, Aquestive is optimistic about addressing the FDA's concerns. The company plans to resubmit the application by the third quarter of 2026. Aquestive is financially stable, expecting to end the year with substantial cash reserves. The company also aims to submit applications for Anaphylm in Canada and the European Union by the end of 2026.

The stock price for AQST is currently $4.18, showing a significant increase of 41.69% with a change of $1.23. The stock has fluctuated between $3.79 and $4.38 during the day. Over the past year, AQST has seen a high of $7.55 and a low of $2.12. The company's market capitalization is approximately $415.1 million, with a trading volume of 44.5 million shares on the NASDAQ exchange.