Aquestive Therapeutics to Join Russell 3000 and 2000 Indexes on June 28, 2024

Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company dedicated to improving patient lives through innovative science and delivery technologies, has announced its anticipated inclusion in the Russell 3000® and Russell 2000® Indexes. The inclusion will take effect from the commencement of U.S. equity markets on July 1, 2024, following the annual reconstitution of the Russell U.S. indexes, as indicated by a preliminary list released on May 24, 2024.

Dan Barber, President and CEO of Aquestive, expressed his honor in joining the Russell 3000 Index, which comprises the 3,000 largest U.S. public companies. He highlighted the benefits of this inclusion, such as increased visibility, awareness, and liquidity, crediting the company's success over the past year for this achievement.

Over the past year, Aquestive has reached significant milestones. They completed a pivotal study for Anaphylm™ (epinephrine) Sublingual Film, which met all predefined primary and secondary endpoints. The FDA also approved Libervant™ (diazepam) Buccal Film for epilepsy patients aged two to five. Additionally, the company raised $77.5 million from notable institutional healthcare investors. Barber noted that the company is progressing with supportive studies for Anaphylm and plans to meet with the FDA soon after their completion. The team is also expanding their commercial infrastructure in anticipation of launching Anaphylm, pending FDA approval, and supporting the recently approved Libervant for young epileptic patients.

The annual reconstitution of the Russell U.S. Indexes ranks the 4,000 largest U.S. stocks by total market capitalization as of April 30th. Membership in the Russell 3000® Index ensures automatic inclusion in either the large-cap Russell 1000® Index or small-cap Russell 2000® Index and corresponding growth and value style indexes. FTSE Russell determines index membership based on market-capitalization rankings and style attributes. The Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.

Aquestive Therapeutics focuses on developing orally administered medications to offer novel alternatives to invasive and inconvenient standard therapies. Their portfolio includes five commercialized products marketed by licensees globally, and they are the exclusive manufacturer of these licensed products. The company collaborates with pharmaceutical firms to bring new molecules to market using proprietary technologies like PharmFilm® and boasts proven drug development and commercialization capabilities. Aquestive's late-stage proprietary pipeline targets central nervous system diseases, with an earlier stage pipeline addressing severe allergic reactions, including anaphylaxis.

Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate. Resembling the size of a postage stamp, it dissolves on contact without the need for water or swallowing. The FDA has conditionally approved the "Anaphylm" tradename, pending final product approval. In March 2024, Aquestive reported positive topline data from a Phase 3 study comparing the pharmacokinetics and pharmacodynamics of Anaphylm to epinephrine intramuscular injections and autoinjectors in healthy adults, meeting all predefined primary and secondary endpoints.

Libervant™ (diazepam) Buccal Film, the first FDA-approved orally administered rescue product for seizure clusters in patients aged two to five, received approval in April 2024. The product treats acute repetitive seizures in epilepsy patients and is available in various dosages. The New Drug Application (NDA) for Libervant for patients aged twelve and older received tentative approval in August 2022 but is subject to an orphan drug exclusivity block until January 2027.

The company also provided detailed safety information on Libervant, highlighting risks such as severe drowsiness, respiratory issues, and potential for abuse, misuse, and addiction. The importance of adhering strictly to prescribed dosages and consulting healthcare providers before combining with other medications was emphasized.

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