Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics (NASDAQ: AQST) announced its participation in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 9, 2024. The event will feature panels discussing key therapeutic themes in immunology, inflammation, and metabolism. The management team of Aquestive will also host investor meetings during the forum. This participation underscores Aquestive's commitment to advancing innovative medicines that significantly improve patients' lives.

Aquestive Therapeutics announced positive topline pharmacokinetic (PK) data from their temperature and pH study of Anaphylm, a sublingual film for treating severe allergic reactions.

The study found that the PK results of Anaphylm were not affected by oral cavity exposure to liquids of different temperatures and pH. Cmax and AUC ratios were consistent across various test conditions, indicating reliable drug performance.

Aquestive remains on track to complete supportive studies and plans to request a pre-NDA meeting with the FDA in Q3 2024, with an NDA filing planned post-pediatric study completion.

Aquestive Therapeutics will join the Russell 3000 and Russell 2000 Indexes, effective June 28, 2024, following the annual reconstitution of the Russell U.S. indexes. This inclusion highlights the company's achievements over the past year, including the successful completion of a Pivotal Study for Anaphylm (epinephrine) Sublingual Film, which met all primary and secondary endpoints, and FDA approval of Libervant (diazepam) Buccal Film for young epilepsy patients. Additionally, Aquestive raised $77.5 million from institutional healthcare investors. CEO Dan Barber emphasized that this milestone increases the company's visibility, awareness, and liquidity as they prepare for the potential market launch of their products, subject to FDA approval.

Aquestive Therapeutics (NASDAQ: AQST) has announced key executive appointments to boost its leadership team ahead of the anticipated launch of Anaphylm™ (epinephrine) Sublingual Film. Sherry Korczynski joins as Senior VP, Sales and Marketing, bringing over 20 years of experience, including roles at Mylan and ANI Pharmaceuticals. Dr. Stephen Wargacki is promoted to Chief Science Officer, having contributed significantly to the company's epinephrine prodrug platform since joining in 2015. Cassie Jung, with two decades at Aquestive, is named Chief Operating Officer, previously overseeing operations and CNS development. These strategic appointments aim to strengthen Aquestive's commercial capabilities and advance the launch of Anaphylm, potentially the first non-invasive epinephrine treatment for severe allergic reactions, pending FDA approval.

Aquestive Therapeutics will present data on Anaphylm™ (epinephrine) sublingual film at the 2024 Eastern Allergy Conference. The presentations will showcase positive pharmacokinetic and pharmacodynamic data from two clinical studies. The Phase 3 pivotal trial for Anaphylm met all expected endpoints, and the company plans to submit a New Drug Application to the FDA by the end of 2024. The conference will be held from May 30 to June 2 in Palm Beach, Florida, featuring experts in allergy, asthma, and immunology.

Aquestive's CEO Dan Barber expressed optimism about Anaphylm's potential to revolutionize severe allergic reaction treatments. The posters will be presented by Dr. Gary Slatko and Dr. David Golden on May 31.

Aquestive Therapeutics, Inc. (AQST) will participate in The Citizens JMP Life Sciences Conference on May 13, 2024. The management team will hold a fireside chat and host investor meetings. A webcast of the chat will be available on the company's website. For more information, visit investors.aquestive.com.

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.