Aquestive Therapeutics, Inc. (AQST), Monday announced that the U.S. Food and Drug Administration has accepted the company's New Drug Application for Anaphylm for the treatment of Type 1 allergic reactions.
Also, the agency has assigned a Prescription Drug User Fee Act target action date of January 31, 2026.
The company further stated that the FDA might decide to conduct an Advisory Committee meeting for the approval of Anaphylm.
If approved, Anaphylm would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States.
In the pre-market hours, AQST is trading at $3.69, up 7.89 percent on the Nasdaq.
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