Levi & Korsinsky LLP
04/16/2026 | Press release | Distributed by Public on 04/16/2026 08:00
Aquestive’s Thin Film, Thick Trouble: Investors Face Fallout From Missed FDA Approval
Aquestive Therapeutics told investors it had developed a breakthrough treatment. A tiny film for severe allergic reactions called Anaphylm. Device free. Easy to carry. Potentially life saving. Executives said the FDA review was on track and approval could come by January 31, 2026. The message stayed the same for months.
In June 2025 the company celebrated the FDA accepting its drug application. By August and November, leadership repeated that everything was moving forward and the launch preparations were already underway. But according to a recently filed securities lawsuit, problems affecting the FDA review were already there.
On January 9, 2026, the truth came out. The FDA had flagged deficiencies that stopped labeling discussions and delayed approval.
Investors were stunned. The stock fell about 37% in a single day. Confidence collapsed.
Now, more investors are joining the lawsuit.
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