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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.
More on Aquestive Therapeutics
- Aquestive Therapeutics: Anaphylm Could Gain Significant Market Share
- Aquestive Therapeutics, Inc. (AQST) Q1 2025 Earnings Call Transcript
- Aquestive Therapeutics: Unprofitable For A Few More Years, But Significant Upside Potential
- Aquestive Therapeutics targets $44M–$50M revenue in 2025 as Anaphylm launch preparations accelerate
- Aquestive Therapeutics Q1 2025 Earnings Preview
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