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 pharmaceutical company that frequently reports on the progress of its proprietary drug delivery technologies and product candidates. Company news often centers on Anaphylm™ (dibutepinephrine) Sublingual Film, a polymer matrix-based epinephrine prodrug product candidate in late-stage development for severe allergic reactions, including anaphylaxis. Press releases describe clinical data, regulatory milestones, and interactions with the U.S. Food and Drug Administration (FDA) and other regulators.
Investors following AQST news can expect updates on the FDA review of the Anaphylm New Drug Application, including communications about advisory committee decisions, review status, and identified deficiencies, as well as the company’s efforts to address regulatory feedback. Aquestive also issues news about its global regulatory strategy for Anaphylm, such as planned and ongoing submissions in Canada, Europe, and the United Kingdom, and feedback from agencies like Health Canada and the European Medicines Agency.
Beyond Anaphylm, Aquestive’s news flow includes developments in its AdrenaVerse™ epinephrine prodrug platform and the AQST‑108 topical gel program for dermatologic conditions, including alopecia areata. The company regularly reports quarterly financial results, outlines its outlook, and discusses manufacturing and royalty-based revenues from licensed products such as Suboxone® Sublingual Film, Sympazan® Oral Film, Ondif® Oral Film, and Azstarys®.
Additional AQST news items cover patent issuances for Anaphylm and related technologies, leadership changes intended to support clinical and commercial execution, participation in healthcare and investor conferences, and financing transactions linked to future product revenues. Readers interested in AQST news can use this page to monitor regulatory, clinical, financial, and strategic announcements that shape the company’s trajectory.
Aquestive Therapeutics (NASDAQ: AQST) has commented on the FDA's recent approval of the first non-injection-based epinephrine device for treating severe allergic reactions, including anaphylaxis. The company views this as a positive development for patients seeking alternatives to needle-based epinephrine delivery. Aquestive is developing its own product, Anaphylm™ (epinephrine) Sublingual Film, which could potentially become the first oral epinephrine treatment for anaphylaxis.
Aquestive reiterates its timeline for Anaphylm™, expecting to file a New Drug Application (NDA) with the FDA in Q1 2025. The company anticipates a full product launch, if approved, by late 2025 or early 2026. Currently, Aquestive is conducting its final supportive study, the oral allergy syndrome (OAS) challenge, expected to conclude in late Q3 or early Q4 2024.
Aquestive Therapeutics (NASDAQ:AQST) reported its Q2 2024 financial results and shared business updates. Key highlights include:
- Anaphylm™ (epinephrine) Sublingual Film remains on track for FDA submission in early 2025, with a potential launch by late 2025 or early 2026.
- Positive topline pharmacokinetic (PK) and pharmacodynamic (PD) data reported, showing no significant differences based on temperature and pH variability.
- Libervant™ (diazepam) Buccal Film expanded for ages two to five, with national retail distribution expected by Q4 2024.
- Q2 2024 revenue surged 52% to $20.1 million, up from $13.2 million in Q2 2023.
- Net loss decreased to $2.7 million from $5.8 million in Q2 2023, with non-GAAP adjusted EBITDA income at $1.8 million.
- Cash reserves stand at approximately $90 million, with a cash runway extending into 2026.
An investor call is scheduled for August 7, 2024, at 8:00 am ET.
Aquestive Therapeutics (NASDAQ: AQST) reported positive topline data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film. The study met primary endpoints, showing comparable pharmacokinetics whether administered by subjects or healthcare providers. Key findings include:
1. No statistical difference between self-administered and HCP-administered Anaphylm
2. Median time to maximum concentration (Tmax) was 15 minutes for Anaphylm vs. 50 minutes for Adrenalin IM injection
3. Oral Allergy Syndrome challenge study currently enrolling, expected to complete in Q3/Q4 2024
4. Company anticipates requesting pre-NDA meeting before end of Q3
5. Full product launch projected for late 2025 or Q1 2026
Aquestive Therapeutics (NASDAQ: AQST) has announced it will report its second quarter 2024 financial results and provide a business update after market close on August 6, 2024. The company, which focuses on developing innovative pharmaceutical delivery technologies, will host a conference call for investors at 8:00 a.m. ET on August 7, 2024. Interested parties can register in advance to obtain call-in details. A live webcast will be available on Aquestive's website, with a replay accessible for 30 days following the call in the Investors section of the company's website.
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.