The complaint alleges that Aquestive provided investors with positive statements while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of Aquestive's New Drug Application (NDA) for Anaphylm (Dibutepinephrine) sublingual film; pertinently, Aquestive concealed or otherwise minimized the significance of the human factors involved in the use and deployment of its sublingual film, such as packaging, use, administration, and labeling. On January 9, 2026, Aquestive announced that the Company was in receipt of a letter from the FDA identifying deficiencies that precluded labeling discussions for Anaphylm. Moreover, Aquestive revealed that the letter from the FDA 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 date. Following this news, the price of Aquestive's common stock declined dramatically. From a closing market price of $6.21 per share on January 8, 2026, Aquestive's stock price fell to $3.91 per share on January 9, 2026, a decline of over 37% in a single day.
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