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Aquestive Therapeutics Announces Resubmission of New Drug Application to FDA for Anaphylm™ (dibutepinephrine) Sublingual Film

Aquestive Therapeutics (AQST)Aquestive TherapeuticsFDA / regulatory

Resubmission supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026 FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission WARREN, N.J., Sept.

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Aquestive Therapeutics

Oral Film Drug Delivery Company Aquestive Therapeutics develops medicines using proprietary film-based delivery technologies for allergic reactions and other conditions. Anaphylm Anaphylm is a postage-stamp-sized sublingual film containing a prodrug of epinephrine for severe allergic reactions, including anaphylaxis. It dissolves without...

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Stock data

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4.44 USD
Market cap
493.02M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States