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Aquestive Therapeutics reported positive results for their Phase 3 study on Anaphylm in Q1 2024, aiming for FDA approval by end of 2024. They also received FDA approval for Libervant for patients ages 2-5. The company extended their cash runway into 2026 through a public offering and continues to progress their pipeline development.
Aquestive Therapeutics has received U.S. FDA approval for Libervant™ (diazepam) Buccal Film for the treatment of seizure clusters in pediatric patients ages 2 to 5, making it the first and only FDA-approved orally administered rescue product for this indication. The company also announced immediate availability of various dosages of Libervant for this patient population. With this approval, Aquestive now has a total of 4 FDA approvals since 2018. Additionally, the company provided an update on its Anaphylm™ (epinephrine) Sublingual Film program, with a planned NDA submission by the end of 2024.