WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST), a pharmaceutical company with a market capitalization of $315 million and impressive 75% stock return over the past year, announced today that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) for its product, Libervant® (diazepam) Buccal Film. According to InvestingPro data, the company has demonstrated strong revenue growth of 22.5% in the last twelve months. This exclusivity applies to the treatment of seizure clusters in young epilepsy patients aged two to five years.
The FDA's decision, which extends market exclusivity for Libervant until April 2031, is based on the product's buccal administration route. The FDA recognizes that this method represents a significant advancement in patient care by offering a non-invasive and easier-to-use option compared to existing rectal gel and nasal spray treatments.
Libervant received FDA approval for this pediatric age group on April 26, 2024, marking it as the first and only orally administered rescue therapy for seizure clusters in these patients. Daniel Barber, CEO of Aquestive, emphasized the company's commitment to educating healthcare providers on Libervant's benefits and ensuring access for the indicated patient population. InvestingPro subscribers can access detailed analysis and 12 additional ProTips about Aquestive's financial health, which currently rates as "Good" according to comprehensive metrics.
The orphan drug status is awarded to treatments for rare diseases or conditions affecting fewer than 200,000 people in the U.S., offering benefits such as financial incentives to support clinical development. Libervant, which was originally granted Orphan Drug Designation on November 10, 2016, is a buccal film formulation of diazepam intended for acute treatment of seizure clusters distinct from a patient's usual seizure pattern.
Aquestive Therapeutics specializes in developing orally administered complex molecule products as alternatives to invasive therapies. The company currently markets five commercialized products and collaborates with other pharmaceutical entities to bring new molecules to market. While maintaining a healthy current ratio of 6.37, indicating strong liquidity, analysts expect continued investment in growth initiatives, though profitability remains a near-term challenge.
This news is based on a press release statement from Aquestive Therapeutics.
In other recent news, Aquestive Therapeutics has been making significant strides in its operations. Cantor Fitzgerald has initiated coverage on Aquestive's shares with an Overweight rating, setting a price target of $17.00. The firm acknowledged Aquestive's proprietary oral film technology, PharmFilm, which has facilitated partnerships and projected revenue growth between $57 million and $60 million for the year 2024.
Aquestive is also advancing its PharmFilm technology for the development of Anaphylm, a treatment for Type 1 allergic reactions. The company plans to submit a New Drug Application (NDA) for Anaphylm in the first quarter of 2025, following a positive pre-NDA meeting with the Food and Drug Administration (FDA).
Lake Street Capital Markets raised the stock price target for Aquestive, reflecting the anticipated impact of the upcoming Anaphylm catalysts. This valuation is based on a projected revenue of $51.0 million for 2025 and the expansion of Aquestive's product pipeline.
Aquestive reported 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.
Finally, Aquestive has seen changes in its board of directors, with Santo J. Costa stepping down and John S. Cochran assuming the role of Chairman of the Compensation Committee. As the company continues to advance its portfolio of treatments, these are the latest developments in its ongoing operations.
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