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Aquestive Therapeutics falls as FDA flags issues with oral allergy drug

ReutersJan 9, 2026 12:27 PM

Shares of drug developer Aquestive Therapeutics AQST.O fall 44% to $3.49 premarket

Co says it received a letter from the U.S. FDA highlighting issues with its new allergy treatment, Anaphylm

FDA raised concerns delaying talks on Anaphylm's labeling and marketing, per co

AQST's Anaphylm is a dissolvable film with epinephrine for severe allergic reactions - AQST

The FDA is expected to make a decision on Anaphylm by January 31, the scheduled action date

Co says if approved, it would be first oral alternative to epinephrine auto-injectors

As of last close, stock up ~81% over the past year

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