On February 2, 2026, New Street initiated coverage of Aquestive Therapeutics with a price target of twelve dollars, implying a potential gain of nearly two hundred percent from current levels. This bullish view reflects confidence in the long-term value of the company’s oral film delivery platform, particularly if regulatory hurdles for its lead candidate are resolved quickly. The forecast underscores anticipated catalysts, including the resubmission of Anaphylm’s New Drug Application and potential approvals in both European and Canadian markets before year-end.

Aquestive received a Complete Response Letter from the U.S. Food and Drug Administration regarding the Anaphylm sublingual film application, citing deficiencies in the human factors validation study. Specifically, the regulator identified challenges with pouch opening mechanics and instances of incorrect film placement that could compromise patient safety during anaphylactic events. In response, the company has redesigned the pouch opening, updated carton and pouch labeling, revised user instructions and will conduct a new human factors validation study in parallel with a targeted pharmacokinetics assessment. Management expects to complete these studies and resubmit the application in early Q3 2026, requesting an expedited review upon filing.

Aquestive’s market capitalization stands at approximately five hundred million dollars, with recent trading volumes averaging over sixty million shares on the NASDAQ exchange. Competitors in the film-based drug delivery space include Teva Pharmaceuticals and Viatris, though Aquestive remains the sole developer of a sublingual epinephrine film for anaphylaxis. The company plans to file for marketing authorization in Europe and a New Drug Submission in Canada in H2 2026, with anticipated U.K. regulatory feedback in Q1 2026. Analyst projections place a final approval decision for Anaphylm in the first half of 2027, setting the stage for potential revenue contributions from this first-in-class product shortly thereafter.