过敏疗法接受FDA审查取得了令人瞩目的进展

2025-06-16 20:23

Aquestive Therapeutics (NASDAQ:AQST) added ~5% in the premarket on Monday after the biopharma announced that the FDA accepted its New Drug Application for allergy therapy Anaphylm for review.
With the NDA, the Warren, New Jersey-based company seeks U.S. approval for Anaphylm, an orally delivered formulation of epinephrine, for anaphylaxis and other Type 1 allergic reactions.
“Anaphylm represents a breakthrough in anaphylaxis treatment, if approved by the FDA, being the first and only device-free, orally delivered epinephrine medicine,” CEO Dan Barber noted, adding, “Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally.”
The company said that the FDA assigned January 31, 2026, as the Prescription Drug User Fee Act (PDUFA) target action date to arrive at a decision on approval and reiterated it might hold an Advisory Committee meeting to discuss the NDA.

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