WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST), a pharmaceutical company, has completed enrollment for its oral allergen challenge study, which is part of the development process for Anaphylm™ (epinephrine) Sublingual Film, a late-stage pipeline program. The company also outlined its strategy for another product candidate, AQST-108 (epinephrine) Topical Gel, aimed at treating Alopecia areata.
Aquestive hosted a virtual investor day to discuss its pipeline, including the two epinephrine-based product candidates. The presentations featured insights from Aquestive management and key opinion leader J. David Farrar, PhD, from UT Southwestern Medical Center. Daniel Barber, President and CEO, noted the company's excitement for the next growth phase and upcoming data from the oral allergy challenge study. He also highlighted the potential of AQST-108 for Alopecia areata treatment due to its differentiated therapeutic profile.
The oral allergy syndrome (OAS) challenge study for Anaphylm is expected to be completed in the fourth quarter of 2024. Aquestive has submitted a pre-NDA meeting request to the FDA and plans to submit an NDA in the first quarter of 2025. If approved, a full product launch is anticipated by early 2026.
AQST-108 (epinephrine) Topical Gel has completed its first human clinical study, which assessed safety and local tolerability. The study found no serious adverse events and consistent epinephrine levels in the skin with zero post-dose plasma concentrations. Aquestive aims to start a Phase 2 study for AQST-108 in the second half of 2025, pending FDA discussions.
Anaphylm™ Sublingual Film is a polymer matrix-based epinephrine prodrug product that dissolves on contact, requiring no water or swallowing. It is designed for convenience and durability. AQST-108 Topical Gel, a prodrug gel product, is based on the company's Adrenaverse™ platform, which targets controlled absorption and conversion rates for various delivery methods.
This news is based on a press release statement from Aquestive Therapeutics. The company is known for advancing orally administered complex molecule treatments and has several commercialized products marketed by licensees. The development of Anaphylm and AQST-108 reflects Aquestive's commitment to addressing severe allergic reactions and dermatological conditions.
In other recent news, Aquestive Therapeutics has made significant strides, notably in gaining FDA approval for a novel non-injection-based epinephrine device for severe allergic reactions. This development marks a departure from the traditional needle-based treatments in use since 1939. Additionally, Aquestive's Anaphylm, an oral epinephrine treatment for severe allergic reactions, is in late-stage development with a New Drug Application (NDA) expected to be submitted to the FDA in the first quarter of 2025.
The company also reported a substantial 52% increase in total revenues for Q2 2024, amounting to $20.1 million, largely driven by license and royalty revenue. However, there was a decrease in manufacture and supply revenue due to order timing and an increase in research and development costs to $4.2 million. As a result, Aquestive revised its 2024 revenue outlook to $57-60 million and anticipates a non-GAAP adjusted EBITDA loss of $20-23 million.
In terms of product development, Aquestive Therapeutics received FDA approval for Libervant for pediatric use and is progressing with its Anaphylm program. The company is preparing for the commercial launch of Anaphylm and exploring partnerships for distribution, indicating a proactive approach to growth and market penetration despite some financial setbacks.
InvestingPro Insights
Aquestive Therapeutics' recent progress in its pipeline development aligns with several key financial metrics and insights from InvestingPro. The company's market capitalization stands at $455.3 million, reflecting investor interest in its potential growth trajectory.
One InvestingPro Tip highlights that Aquestive holds more cash than debt on its balance sheet, which is crucial for a pharmaceutical company investing heavily in research and development. This financial stability supports the company's ability to fund its ongoing clinical trials and product development efforts, including the Anaphylm™ Sublingual Film and AQST-108 Topical Gel.
Another relevant InvestingPro Tip indicates that Aquestive has experienced a strong return over the last three months, with the stock price showing a remarkable 93.05% total return over this period. This surge in investor confidence may be attributed to the positive developments in the company's pipeline, particularly the completion of enrollment for the oral allergen challenge study.
It's worth noting that InvestingPro Data shows a significant revenue growth of 51.79% in the most recent quarter, which could be indicative of increasing market traction for Aquestive's existing products. This growth trajectory bodes well for the company's ability to support its ambitious development plans for new treatments.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights that could provide a fuller picture of Aquestive Therapeutics' financial health and market position.
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