Alliance Global notes Aquestive Therapeutics (AQST) has announced that the FDA had issued a Complete Response Letter on January 30, 2026, for the New Drug Application of Anaphylm Sublingual Film for the treatment of Type I allergic reactions. In the CRL, the FDA notes deficiencies solely limited to the packaging and administration of Anaphylm, which the company plans to address quickly through the initiation of a new human factors validation study and pharmacokinetics study. Management details that they aim to conduct these studies in parallel, with an expected completion and resubmission of the NDA by Q3 2026. While this is an aggressive timeline, the firm believes it is do-able by Aquestive Therapeutics as they bring “all hands on deck” to get it done. With an aggressive plan for a quick Anaphylm resubmission in place, Alliance Global is reiterating a Buy rating and $12 price target on the shares.
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- Buy Rating Maintained on Aquestive Therapeutics as FDA CRL Seen as Operational Setback with Manageable Risk and Attractive Long‑Term Risk‑Reward
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