Aquestive Therapeutics (AQST): A Fresh Look at Valuation After FDA Advances Sublingual Epinephrine Film

If you have been eyeing Aquestive Therapeutics (AQST), recent developments may prompt you to take another look. The buzz centers on news that the FDA has waived the advisory committee meeting for Anaphylm, the company’s sublingual epinephrine film for severe allergic reactions. For investors, this move is significant, as it generally signals reduced regulatory hurdles and greater confidence in an eventual approval. The major Prescription Drug User Fee Act decision date is now set for January 31, 2026. If approved, Anaphylm could become the first FDA-approved, non-invasive epinephrine product, a feat that would set it apart in a market currently dominated by injectors.

The stock has responded in kind, jumping 28% in the past month, despite a 5% decline over the last year and decreased revenue. This sharp turn in sentiment highlights how much weight the market is placing on the company’s prospects for breakthrough growth. Despite past revenue drops, investors seem willing to look past near-term setbacks as they bet on Anaphylm’s potential market impact. With momentum clearly picking up, the narrative has shifted from justifying past performance to evaluating future upside.

With the stock making such a strong run ahead of a pivotal decision, the big question is whether there is still room to buy at value or if the current price already reflects the hope of future success.

Most Popular Narrative: 33.9% Undervalued

According to the most closely watched valuation narrative, Aquestive Therapeutics is currently trading at a sizeable discount to its estimated fair value, creating the perception of a potentially overlooked opportunity. The narrative positions the stock as undervalued, with room for upside if the company executes on its strategy.

Broad physician and patient preference for non-injectable formats, coupled with survey data indicating significant anticipated market share shift toward these alternatives, suggests Anaphylm could accelerate prescription volumes and, if adopted, drive substantial topline revenue expansion.

Curious what is fueling this bullish outlook? Behind the scenes are aggressive numbers for future sales, razor-focused strategies, and a projected profit surge if everything clicks. Want to see exactly which big assumptions could move AQST from deep in the red to industry profit territory? The full narrative lays out all the bold bets that make up this valuation math.

Result: Fair Value of $8.58 (UNDERVALUED)

Have a read of the narrative in full and understand what's behind the forecasts.

However, delays in Anaphylm’s approval or tougher-than-expected payer coverage could still limit Aquestive’s ability to deliver on bullish projections.

Find out about the key risks to this Aquestive Therapeutics narrative.

Another View: Market-Based Valuation Sends a Different Signal

Looking at a common market-based approach, the latest numbers suggest Aquestive Therapeutics trades at a much higher valuation than the industry. This paints a less optimistic picture compared to some other models. Which story should investors trust?

See what the numbers say about this price — find out in our valuation breakdown.

Stay updated when valuation signals shift by adding Aquestive Therapeutics to your watchlist or portfolio. Alternatively, explore our screener to discover other companies that fit your criteria.

Build Your Own Aquestive Therapeutics Narrative

If the current analysis doesn’t quite align with your perspective or you want to dive deeper into the numbers yourself, you can craft your own narrative in just a few minutes. Do it your way.

A great starting point for your Aquestive Therapeutics research is our analysis highlighting 2 key rewards and 4 important warning signs that could impact your investment decision.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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