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Aquestive Therapeutics Awaits FDA Decision on Anaphylm NDA

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Aquestive Therapeutics Awaits FDA Decision on Anaphylm NDA

Aquestive Therapeutics ( (AQST) ) has issued an update.

On April 1, 2025, Aquestive Therapeutics announced positive results from its pediatric study for Anaphylm™ (epinephrine) Sublingual Film, marking the completion of its clinical program. The company has submitted a New Drug Application (NDA) to the FDA, expecting potential acceptance in the second quarter of 2025. The study involved patients aged seven to seventeen, showing consistent pharmacokinetic results with previous adult studies, and no serious adverse events were reported. Aquestive plans to launch Anaphylm in the first quarter of 2026, pending FDA approval.

More about Aquestive Therapeutics

Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies. The company develops orally administered products to provide novel alternatives to invasive and inconvenient standard care therapies. Aquestive has five commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm®.

YTD Price Performance: -20.98%

Average Trading Volume: 1,654,706

Technical Sentiment Signal: Buy

Current Market Cap: $298.6M

For a thorough assessment of AQST stock, go to TipRanks’ Stock Analysis page.

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