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WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST), a pharmaceutical company focused on developing innovative medications, has acknowledged the U.S. Food and Drug Administration's (FDA) approval of a novel non-injection-based epinephrine device for severe allergic reactions. This marks a significant shift from traditional needle-based epinephrine treatments that have been standard since 1939.
Daniel Barber, President & CEO of Aquestive, expressed optimism about the FDA's decision, noting that patient adherence and compliance are likely to improve with less invasive options. The company is also developing its own product, Anaphylm™ (epinephrine) Sublingual Film, which is poised to be the first oral epinephrine treatment for severe allergic reactions, including anaphylaxis, pending FDA approval.
The medical community, including Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education), and John Oppenheimer, MD, has welcomed the FDA's approval, citing the importance of needle-free options in reducing injection hesitancy and potentially saving lives.
Aquestive's Anaphylm is currently in late-stage development, with its oral allergy syndrome (OAS) challenge study expected to be completed in late third quarter or early fourth quarter of 2024. The company anticipates submitting a New Drug Application (NDA) to the FDA in the first quarter of 2025 and, if approved, launching Anaphylm at the end of 2025 or in early 2026.
Anaphylm is designed as a sublingual film that dissolves upon contact, eliminating the need for water or swallowing. Its packaging is intended to be durable and easily portable, further enhancing patient convenience.
The information in this article is based on a press release statement.
In other recent news, Aquestive Therapeutics reported a substantial 52% increase in total revenues for Q2 2024, amounting to $20.1 million. This growth was primarily driven by license and royalty revenue. The company also announced the FDA approval of Libervant for pediatric use and the progression of its Anaphylm program, with an NDA filing expected in December 2024.
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. Aquestive has revised its 2024 revenue outlook to $57-60 million and anticipates a non-GAAP adjusted EBITDA loss of $20-23 million.
These developments underline Aquestive's strategic positioning in the pharmaceutical market, with innovative products and a focus on profitable collaborations. Despite some financial setbacks, the company's revised outlook and strategic planning indicate a proactive approach to growth.
InvestingPro Insights
As Aquestive Therapeutics, Inc. (NASDAQ: AQST) garners attention with its FDA-approved non-injection epinephrine device, the company's financial health and stock performance are key areas of interest for investors. According to InvestingPro data, Aquestive Therapeutics currently holds a market capitalization of $356.95 million, reflecting its valuation within the pharmaceutical industry. Despite challenges, the company has shown a robust revenue growth of 25.45% over the last twelve months as of Q2 2024, which may indicate a positive reception to its innovative product pipeline.
InvestingPro Tips suggest that the company's financial position is solid, with more cash than debt on its balance sheet, providing a degree of financial stability as it progresses with product development. Additionally, Aquestive's liquid assets exceed its short-term obligations, offering further reassurance about the company's ability to meet its immediate financial commitments.
Nevertheless, analysts have revised their earnings expectations downwards for the upcoming period, and the consensus view is that the company will not be profitable this year. These contrasting indicators highlight the speculative nature of the investment, which is also evident in the stock's volatility and the lack of dividends paid to shareholders.
Investors tracking AQST's stock performance will note the significant return over the last week, with a 14.29% price total return, and even more impressive gains over the last month and six months, at 46.82% and 46.27% respectively. The strong return over the last three months of 22.5% and an extraordinary year-to-date price total return of 94.06% may reflect market optimism towards the company's future prospects.
For those considering an investment in Aquestive Therapeutics, there are 13 additional InvestingPro Tips available, which can provide more detailed insights into the company's financial metrics and stock performance. Visit InvestingPro for AQST to explore these tips and to leverage the InvestingPro platform's comprehensive analysis tools.
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