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WARREN, N.J. - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company with a market capitalization of $725 million and whose stock is trading near its 52-week high of $6.43, announced Wednesday that the United States Patent and Trademark Office has issued two additional patents for its Anaphylm dibutepinephrine sublingual film, extending protection until at least 2037.
The patents cover the proprietary composition for the company’s epinephrine prodrug sublingual film, which is designed as an oral alternative to injectable epinephrine for treating severe allergic reactions, including anaphylaxis.
"These claims cover the proprietary composition for Anaphylm, which enables the oral sublingual film delivery of an epinephrine prodrug," said Dan Barber, President and CEO of Aquestive, in a press release statement.
The newly issued patents include U.S. patent number 12,427,121 entitled "Enhanced Delivery Epinephrine Compositions," and U.S. patent number 12,443,850 entitled "Enhanced Delivery Epinephrine and Prodrug Compositions."
If approved by the FDA, Anaphylm would be the first oral medication for the emergency treatment of severe allergic reactions. The product is a thin film that dissolves when placed under the tongue, requiring no water or swallowing. According to the company, the packaging is smaller than a credit card and designed to withstand weather exposure. Wall Street analysts maintain a bullish outlook on the company’s prospects, with price targets reaching as high as $15 per share. According to InvestingPro, the stock has delivered an impressive 151.9% return over the past six months.
The FDA has scheduled a Prescription Drug User Fee Act target action date of January 31, 2026, for Anaphylm.
Anaphylaxis is a severe, potentially life-threatening allergic reaction that requires immediate administration of epinephrine, but many patients may hesitate to use traditional injections due to needle anxiety.
The information in this article is based on a press release from Aquestive Therapeutics. The company maintains a strong liquidity position with a current ratio of 3.53, indicating its ability to meet short-term obligations. For deeper insights into Aquestive’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, available alongside 12+ additional exclusive ProTips for informed investment decisions.
In other recent news, Aquestive Therapeutics announced that the U.S. Food and Drug Administration will not require an advisory committee meeting for its Anaphylm Sublingual Film, keeping the company on track for a regulatory decision by January 31, 2026. This development is crucial as the Anaphylm product offers a non-invasive alternative for treating severe allergic reactions. Additionally, Aquestive has secured a $75 million strategic funding agreement with RTW Investments, contingent on FDA approval of Anaphylm, to aid in its commercialization through 2027.
In financial maneuvers, the company has priced an underwritten public offering of 21,250,000 shares at $4.00 per share, expected to generate $85 million in gross proceeds. Piper Sandler has reiterated its Overweight rating on Aquestive stock, backed by positive feedback from allergists regarding Anaphylm’s convenience and dosing profile. Similarly, Cantor Fitzgerald maintains an Overweight rating with a $15.00 price target, highlighting the potential market shift towards needle-less epinephrine delivery methods. These developments underscore the ongoing interest and potential in Aquestive’s innovative approaches in the epinephrine market.
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