WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST), a pharmaceutical company with a market capitalization of $464 million and an impressive year-to-date stock return of 152%, has announced that the U.S. Food and Drug Administration (FDA) has provided positive feedback on the company's development program for Anaphylm™ (epinephrine) Sublingual Film. According to InvestingPro data, analysts have set price targets ranging from $5.50 to $15.00 for the stock. This feedback confirms that no additional adult clinical trials are required before the New Drug Application (NDA) submission, which is expected in the first quarter of 2025.
The company has also initiated a pediatric trial in the United States and Canada for Anaphylm, which is a potential treatment for severe allergic reactions, including anaphylaxis. If approved, Anaphylm would be the first orally administered epinephrine product on the market, offering an alternative to the current epinephrine auto-injectors.
Daniel Barber, President and CEO of Aquestive, stated that the FDA's alignment on the adult development program represents a significant step forward for the company and those affected by severe allergies. The company maintains a "Good" financial health score according to InvestingPro analysis, with strong liquidity metrics showing current assets exceeding short-term obligations by more than six times. He emphasized the potential impact of Anaphylm on the patient community, citing the ease of carrying and administering the product as a transformative advancement over existing options.
The FDA's written response to Aquestive's planned NDA included agreement on the content and format of the submission, the safety evaluation plan, and the ongoing pediatric trial. The agency also suggested additional data views for the NDA and requested minor modifications to the pediatric trial protocol, which Aquestive has incorporated without expecting any significant delays.
Anaphylm is designed to be discreet and user-friendly, similar in size to a postage stamp, and does not require water or swallowing for administration. Its packaging is intended to withstand environmental factors such as rain and sunlight. The FDA has conditionally approved the trade name Anaphylm, with final approval contingent on the product candidate's approval.
Aquestive Therapeutics focuses on developing orally administered complex molecule treatments and has commercialized five products, in addition to Anaphylm, for various indications. The company has demonstrated solid revenue growth of 22.6% over the last twelve months and maintains more cash than debt on its balance sheet. The information in this article is based on a press release statement from Aquestive Therapeutics. For a comprehensive analysis of AQST's financial health, growth prospects, and valuation metrics, access the detailed Pro Research Report available exclusively on InvestingPro.
In other recent news, Aquestive Therapeutics reported a reshuffling in its board of directors, with Santo J. Costa stepping down and John S. Cochran assuming the role of Chairman of the Compensation Committee. These changes occur as the company continues to navigate the competitive pharmaceutical industry landscape. In financial developments, Aquestive Therapeutics announced a growth in its Q3 2024 financial results, with total revenue reaching $13.5 million, a 4% increase from the same period last year. However, excluding one-time revenue from a terminated agreement, revenues saw a 5% decline. The company also experienced a net loss of $11.5 million for Q3 2024, widening from a $2 million loss in Q3 2023. In product updates, the company is progressing with its lead product candidate, Anaphylm, which has received positive feedback from the FDA, and expanding the Libervant launch for young children. Aquestive Therapeutics is also preparing for Anaphylm's potential launch in Q1 2026 and AQST-108's launch before the end of 2028.
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