Positive Outlook for Aquestive Therapeutics Amidst FDA Progress and Strategic Preparations for Anaphylm Launch

Leerink Partners analyst Roanna Ruiz has maintained their bullish stance on AQST stock, giving a Buy rating on June 17.

Roanna Ruiz’s rating is based on several promising developments for Aquestive Therapeutics. The FDA’s timely acceptance of the New Drug Application (NDA) for Anaphylm, an oral epinephrine film, with a PDUFA action date set for January 31, 2026, is a significant milestone. This acceptance provides a clear path toward potential approval for treating Type 1 allergy and anaphylaxis, especially following ARS Pharma’s neffy in the US market.
Moreover, Ruiz highlights the company’s proactive steps in preparing for a possible advisory committee meeting and the potential US launch of Anaphylm in 2026. Aquestive is conducting market research and building early commercial infrastructure, which is expected to expand further into the fourth quarter of 2025. The management’s indication of smooth interactions with the FDA and the lower risk of PDUFA delays due to current FDA capacity are also seen as positive signs. These factors collectively contribute to Ruiz’s Buy rating for Aquestive Therapeutics.

According to TipRanks, Ruiz is an analyst with an average return of -12.1% and a 32.33% success rate. Ruiz covers the Healthcare sector, focusing on stocks such as Cytokinetics, United Therapeutics, and Cormedix.

In another report released on June 17, Raymond James also maintained a Buy rating on the stock with a $7.00 price target.