A class action lawsuit was filed against Aquestive Therapeutics (AQST) on March 5, 2026.
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The federal securities class action alleges that plaintiffs acquired Aquestive stock at artificially inflated prices between June 16, 2025 and January 8, 2026, known as the “Class Period.” Plaintiffs are now seeking compensation for financial losses incurred upon public revelation of the company’s alleged misconduct during that time. To learn whether you may be eligible for a recovery under this securities lawsuit, click here.
What Does AQST Do?
AQST is a pharmaceutical company that advances various medicines through the use of “innovative science and delivery technologies.’
The company develops products that can be given/taken by mouth to facilitate the delivery of complex molecules. By doing so, Aquestive claims it provides new alternatives to “invasive and inconvenient standard of care therapies.”
Aquestive licensees market four commercialized products in the United States and globally. No one else makes these particular products, the company says. In addition to making its own products, the company teams up with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, such as PharmFilm.
Among other things, Aquestive says it is promoting a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis. Aquestive also says it is working on an earlier stage “epinephrine prodrug topical gel product candidate for possible various dermatology conditions.”
The company’s claims about its New Drug Application (NDA) for Anaphylm (Dibutepinephrine) sublingual film are at the crux of the current complaint.
It has said that Anaphylm, similar in size to a postage stamp, can be an oral alternative to Epinephrine injections for anaphylaxis.
Why are Investors Suing AQST?
The company and its CEO (the “Individual Defendant”) are accused of deceiving investors by lying and withholding critical information about Aquestive’s business and prospects during the Class Period. Specifically, they are accused of omitting truthful information about the timeline for approval and launch for Aquestive’s NDA for Anaphylm (Dibutepinephrine) sublingual film from SEC filings and related material. By knowingly or recklessly doing so, they allegedly caused Aquestive stock to trade at artificially inflated prices during the time in question.
The truth, according to investors, came out on January 9, 2026. That’s when Aquestive announced that it received a letter from the U.S. Food and Drug Administration (FDA) “identifying deficiencies that precluded labeling discussions for Anaphylm.” In this context, the company also revealed that the FDA’s letter “confirmed that the Agency’s review of Anaphylm NDA was ongoing and no final decision had been made, which effectively delayed the approval of Anaphylm well beyond the January 31, 2026 [Prescription Drug User Fee Act] PDUFA date.”
Taking a Closer Look
As alleged, Aquestive and/or the Individual Defendant repeatedly made false and misleading public statements throughout the Class Period.
In a press release issued at the beginning of the Class Period, for instance, Aquestive’s CEO stated in relevant part: “Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally. With the FDA’s acceptance of our NDA, we’re one step closer to getting this life-saving innovation in the hands of the patients and caregivers who need it most.”
Next, during an August 12, 2025 earnings call, the company’s CEO stated: “I’m pleased to tell you this morning that we are on track across the important elements of Anaphylm. We are on track in our FDA review process, our Anaphylm advisory committee preparations, which may or may not occur, and our pre-commercial launch activities.”
Finally, during a November 6, 2025 earnings call, Aquestive’s CEO stated in relevant part: “Now let’s turn to the FDA. Given the government shutdown, we requested the FDA to provide us with a status update on the review timing of our filings. I am pleased to say that as of this last update, the FDA confirmed they are aiming for an on-time review of our application.”
Actions You May Take
If you have purchased the company’s stock during the Class Period, you may join the class action as a lead plaintiff, remain a passive class member, or opt out of this litigation and pursue individual claims that may not be available to the class as a whole. To learn more about your options, click here.
The deadline to file for lead plaintiff in this class action is May 4, 2026.