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WARREN, N.J. - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company with a market capitalization of $400 million and showing strong momentum with a 9.5% return last week, announced today that Health Canada has granted the company a meeting to discuss its planned New Drug Submission for Anaphylm Sublingual Film, scheduled for the third quarter of 2025. According to InvestingPro analysis, the stock’s RSI suggests it’s currently in overbought territory.
The pharmaceutical company has also submitted an initial briefing book to the European Medicines Agency (EMA) as part of its plans to file a Marketing Authorization Application for the needle-free epinephrine product.
These regulatory activities represent the first steps in Aquestive’s international regulatory strategy for Anaphylm, which is currently under review by the U.S. Food and Drug Administration with a target action date of January 31, 2026.
"These regulatory activities mark the pivotal first steps in Aquestive’s comprehensive ex-U.S. regulatory strategy," said Dan Barber, President and Chief Executive Officer of Aquestive.
Unlike traditional epinephrine auto-injectors, Anaphylm is a sublingual film that dissolves in the mouth without requiring needles or devices. The product is designed to be smaller than a postage stamp and can be carried in a pocket.
The company reports it has six FDA-approved drugs in its portfolio with products available across six continents, which it believes positions it well for navigating international approval processes.
Aquestive’s international strategy focuses initially on Canada and European markets, which the company describes as having collaborative regulatory environments and substantial populations requiring anaphylaxis treatment options.
This information is based on a press release statement from Aquestive Therapeutics.
In other recent news, Aquestive Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application for Anaphylm, a sublingual epinephrine film for treating severe allergic reactions. The FDA set a target action date of January 31, 2026, and may hold an Advisory Committee meeting during the review process. Aquestive’s first-quarter 2025 financial results showed a challenging period, with earnings per share of -$0.24 missing the forecast and revenue at $8.7 million, below the expected $12.23 million. Following these results, Oppenheimer adjusted its price target for Aquestive from $15.00 to $7.00 but maintained an Outperform rating, while Raymond James also reaffirmed an Outperform rating with a $7.00 target. The company’s focus remains on Anaphylm, with ongoing preparations for its potential launch in early 2026. Aquestive is also engaging with payers and regulators outside the United States to strengthen its market presence. The company has revised its 2025 revenue guidance to $44-$50 million, reflecting its strategic focus on Anaphylm.
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