Welcome to our dedicated page for Aquestive Therapeutics news (Ticker: AQST), a resource for investors and traders seeking the latest updates and insights on Aquestive Therapeutics stock.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a specialty pharmaceutical innovator developing non-invasive therapies for central nervous system disorders and severe allergic reactions. This page serves as the definitive source for official company announcements, regulatory updates, and strategic developments.
Investors and industry stakeholders will find timely updates on product approvals, clinical trial milestones, licensing agreements, and financial performance. Our curated feed includes press releases related to Aquestive’s proprietary PharmFilm® technology, partnership expansions, and advancements in treatments like anaphylaxis management solutions.
All content is organized to provide clear insights into the company’s progress in addressing complex medical needs through innovative drug delivery systems. Key areas of coverage include FDA communications, research breakthroughs, and market expansion initiatives that underscore Aquestive’s role in reshaping patient care paradigms.
Bookmark this page for direct access to primary-source information about AQST’s scientific advancements and corporate strategy. Check regularly for updates that matter to your analysis of this pioneering healthcare company.
Aquestive Therapeutics (NASDAQ:AQST), a pharmaceutical company focused on developing innovative medicines and delivery technologies, has announced its participation in the upcoming Piper Sandler Spring Biopharma Symposium in Boston. The company's management team will conduct investor meetings during the event scheduled for April 17, 2025.
Aquestive Therapeutics (NASDAQ: AQST) has announced positive topline pharmacokinetic (PK) results from its pediatric study of Anaphylm™, an epinephrine sublingual film for severe allergic reactions. The study, involving 32 patients aged 7-17 weighing over 30kg, demonstrated consistent PK profiles with previous adult studies, with no serious adverse events reported.
The company has completed and submitted its New Drug Application (NDA) to the FDA, with expected acceptance in Q2 2025. If approved, Anaphylm™ would become the first-ever sublingual film treatment for anaphylaxis, with a planned commercial launch in Q1 2026. The pediatric study results support potential label inclusion for this age group.
Aquestive Therapeutics (NASDAQ: AQST) has initiated the NDA filing process for Anaphylm™, their non-device epinephrine sublingual film, with expected launch in Q1 2026 if approved. Initial pediatric trial results for ages 7-17 align with expectations.
Q4 2024 financial highlights: Revenue decreased 10% to $11.9 million, with net loss of $17.1 million ($0.19 per share). Full year 2024 saw revenue increase 14% to $57.6 million, though net loss widened to $44.1 million ($0.51 per share).
Key developments include:
- AQST-108 epinephrine topical gel Phase 2a trial to begin Q2 2025
- Libervant® received FDA approval for patients aged 2-5 years with Orphan Drug Exclusivity until April 2031
- Proforma cash position of approximately $93.0 million as of December 31, 2024
Aquestive Therapeutics (NASDAQ:AQST) has announced its participation in two major investor conferences in March 2025. The company will attend:
- Leerink's Global Biopharma Conference 2025 (March 10-12), featuring a fireside chat on March 10th from 4:20-4:50pm EST
- Barclays 27th Annual Global Healthcare Conference (March 11-13), with management available for meetings on March 12th
The Leerink conference presentation will be webcast and available on the company's investor relations website under 'Events and Presentation,' with replay access for 30 days post-event. Management will be available for one-on-one meetings at both conferences.
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.
