Aquestive Therapeutics - AQST STOCK NEWS

Aquestive Therapeutics (NASDAQ: AQST) has scheduled its fourth quarter 2024 financial results announcement for March 5, 2025, after market close. The pharmaceutical company will host a conference call for investors on March 6, 2025, at 8:00 a.m. ET to discuss the results and provide updates on recent business developments.

Investors can participate in the conference call by registering in advance to obtain their local or toll-free phone number and personal pin. A live webcast will be available on the Investors section of Aquestive's website, with a 30-day archive period following the call.

Aquestive Therapeutics (NASDAQ: AQST) has announced new findings on Anaphylm™, their investigational epinephrine sublingual film for treating severe allergic reactions, to be presented at the 2025 AAAAI Annual Meeting in San Diego.

Key findings from the Phase 2 OASIS study (n=36) show that Anaphylm matched or exceeded intramuscular epinephrine in all key pharmacokinetic parameters. The median symptom resolution time was 12 minutes compared to 74 minutes without treatment, with mean angioedema symptom resolution within 5 minutes.

The research demonstrates that Anaphylm maintains stability and potency under extreme conditions, including heat, freezing, and water submersion. The drug's performance was not impacted by oral swelling, and its effectiveness remained consistent regardless of oral allergen challenge conditions.

Aquestive Therapeutics (NASDAQ:AQST), a pharmaceutical company focused on innovative medicine delivery technologies, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The virtual event will take place from February 11-12, 2025.

The company's management team will conduct a fireside chat on February 11th at 3:20pm ET. Investors and interested parties can access the webcast through the 'Events and Presentations' section of Aquestive's investor relations website. A replay will remain available for 30 days after the event.

Aquestive Therapeutics (NASDAQ: AQST) provided a business update and outlined key objectives for 2025. The company reported unaudited cash and cash equivalents of approximately $70 million as of December 31, 2024.

Key developments include: planned submission of Anaphylm™ (epinephrine) Sublingual Film NDA in Q1 2025, ongoing pediatric clinical trial recruitment, and successful completion of AQST-108 topical gel pre-IND meeting with FDA clearance to begin Phase 2a trial for alopecia areata in Q2 2025.

The company received FDA approval and Orphan Drug Exclusivity until April 2031 for Libervant®, the first FDA-approved oral rescue treatment for seizure clusters in pediatric patients aged 2-5 years. Aquestive's 2025 strategy focuses on Anaphylm's potential U.S. launch in Q1 2026, expanding ex-U.S. development, conducting AQST-108 trials, growing Libervant sales, and transitioning from legacy products to growth opportunities.

Aquestive Therapeutics announced that the U.S. FDA has granted Orphan Drug Exclusivity (ODE) to Libervant® (diazepam) Buccal Film for pediatric patients aged 2 to 5 with seizure clusters. The ODE provides seven years of market exclusivity in the United States, extending until April 2031. Libervant, approved on April 26, 2024, offers a non-invasive, orally administered rescue therapy for acute repetitive seizures, providing a significant improvement over rectal administration.

Daniel Barber, CEO of Aquestive, emphasized the importance of this treatment in providing ease of use for patients and caregivers. The FDA's decision acknowledges the major contribution of Libervant's buccal route to patient care. The Orphan Drug Designation, initially granted on November 10, 2016, supports the development of treatments for rare diseases, offering financial incentives and market exclusivity upon regulatory approval.

Libervant is the first and only FDA-approved orally administered rescue product for this patient population.

Aquestive Therapeutics (NASDAQ: AQST) received positive FDA feedback regarding its planned NDA submission for Anaphylm™, a potential first-ever orally delivered epinephrine product for severe allergic reactions treatment. The FDA agreed with the company's planned NDA content, format, safety evaluation, and pediatric trial design, which has begun in the U.S. and Canada. The company reaffirmed its NDA submission timeline for Q1 2025, with no additional adult clinical trials required. The FDA indicated a possible advisory committee meeting due to the novel route of administration. Anaphylm aims to serve an estimated 33 million Americans with food allergies who currently rely on epinephrine medical devices.

Aquestive Therapeutics (NASDAQ:AQST) has announced its participation in two major healthcare investor conferences. The company will attend the Jefferies London Annual Healthcare Conference from November 19-21, 2024, offering one-on-one meetings with management. Additionally, they will participate in Piper Sandler's 35th Annual Healthcare Conference on December 4th, 2024, featuring a fireside chat at 1:30 PM ET and one-on-one meeting opportunities.

The Piper Sandler presentation will be webcast and available on the company's website under the 'Events and Presentation' section, with replay access for 30 days post-event.

Aquestive Therapeutics (NASDAQ:AQST) reported Q3 2024 financial results with total revenues of $13.5 million, up 4% from Q3 2023. The company reported a net loss of $11.5 million ($0.13 per share). Key developments include positive topline data from the OASIS study for Anaphylm™, their oral epinephrine treatment, with a pre-NDA meeting scheduled for Q4 2024. The company maintains $77.9 million in cash and expects a cash runway into 2026. Full-year 2024 guidance projects revenue of $57-60 million with a non-GAAP adjusted EBITDA loss of $20-23 million.

Aquestive Therapeutics (NASDAQ: AQST) announced a subsequent analysis of their pivotal study for Anaphylm™ (epinephrine) Sublingual Film to be presented at the ACAAI 2024 Annual Meeting. The analysis demonstrates that the film maintains consistent pharmacokinetics and pharmacodynamics regardless of placement or movement in the mouth.

The study showed that 87.5% of subjects had no change in film location between 1.5 to 3 minutes after administration. In cases where movement occurred (12.5% of subjects), there were no significant differences in drug concentration metrics. The geometric mean maximum concentration was 351.14 and 490.27 pg/mL for subjects with and without film movement, respectively, with a median peak drug concentration of 12 minutes for both groups.