Aquestive Therapeutics Reports Topline Data From Temperature / pH Study Of Anaphylm Sublingual Film
Portfolio Pulse from Benzinga Newsdesk
Aquestive Therapeutics (NASDAQ:AQST) reported positive topline data from a temperature/pH study of its Anaphylm Sublingual Film, showing that pharmacokinetic results were unaffected by oral cavity exposure to liquids of different temperatures and pH. The company remains on track to complete supportive clinical studies and expects to request a pre-NDA meeting with the FDA in Q3 2024, with plans to file a New Drug Application shortly after completing its pediatric study.
June 25, 2024 | 12:05 pm
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Aquestive Therapeutics reported positive topline data for its Anaphylm Sublingual Film, showing stability in pharmacokinetic results despite varying temperatures and pH levels. The company is on track for a pre-NDA meeting with the FDA in Q3 2024 and plans to file an NDA shortly after completing its pediatric study.
The positive topline data and the company's clear regulatory timeline are likely to boost investor confidence. The stability of Anaphylm under different conditions is a significant milestone, and the upcoming pre-NDA meeting with the FDA adds to the positive outlook.
CONFIDENCE 90
IMPORTANCE 80
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