Aquestive Therapeutics, Inc. Common Stock
AQSTAquestive Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing medicines to address unmet medical needs. The company specializes in developing proprietary formulations of drugs for respiratory, epilepsy, and other disorders, utilizing its core patent-protected oral and transdermal technologies.
Company News
Aquestive Therapeutics received an FDA letter identifying deficiencies in its Anaphylm (dibutepinephrine) sublingual film NDA that preclude labeling discussions, though the FDA confirmed its review remains ongoing with no final decision made. The company maintains confidence in Anaphylm's potential and is advancing global regulatory expansion in ...
The food allergy market is expected to grow significantly by 2034, driven by emerging therapies, increased diagnoses, and rising treatment costs. The market was valued at USD 3 billion in 2024, with the US accounting for approximately 79% of the total market.
Aquestive Therapeutics received two new U.S. patents for Anaphylm, a sublingual film for treating severe allergic reactions, extending product protection through 2037. The FDA's PDUFA target action date is set for January 31, 2026.
Aquestive Therapeutics reports the FDA will not require an advisory committee meeting for its Anaphylmâ„¢ (dibutepinephrine) Sublingual Film, maintaining the PDUFA target action date of January 31, 2026. The product aims to be the first non-invasive, orally delivered epinephrine treatment for severe allergic reactions.
Aquestive Therapeutics secured a $75 million strategic funding agreement with RTW Investments to support the potential launch of Anaphylm, an innovative sublingual epinephrine film for treating severe allergic reactions, pending FDA approval.
