Sep. 21, 2025 at 12:49 PM ET6 min read

Aquestive Therapeutics Stock Surges on FDA Approval and Analyst Upgrades

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Written by Tim Bohen Reviewed by Ben Sturgill Fact-checked by Ellis Hobbs

Aquestive Therapeutics Inc. stocks have been trading up by 15.34 percent driven by positive FDA designation news.

Market Insights

  • The FDA’s recent decision not to require an advisory committee meeting for Anaphylm, a sublingual film designed for severe allergic reactions, has spurred optimism. This development has significantly buoyed market sentiment, marking a pivotal step toward product approval with the target action date set for January 31, 2026.

Healthcare industry expert:

Analyst sentiment – positive

Aquestive Therapeutics (AQST) is facing significant operational and financial challenges as evident from its negative profit margins and diminishing revenue trends over the past years. The company, with a gross margin of 61.1%, is unable to leverage its cost advantage, reflecting in dismal profitability metrics, including an EBIT margin of -130.8% and a net profit margin (total) of -147.38%. The valuation measures exhibit a concerning picture, notably a price-to-sales ratio of 12.81 and a negative book value per share of -0.73, suggesting the stock is overvalued relative to fundamentals. Despite this, the company maintains a stable liquidity position with a current ratio of 3.5. Overall, AQST’s fundamentals reveal a company in distress, struggling to convert potential into profitability.

Recent price actions present a mixed technical outlook for AQST. The price chart shows a relatively stable trend with minor fluctuations between $4.86 and $5.6978, despite a brief surge over the examined period. Notably, there is a resistance around $5.70 and visible support around $4.86. With the current price pattern and recent consolidation near the resistance, traders might look for a break above the $5.70 level for potential upside or a breach below $4.86 for downside. The volume analysis indicates increasing buying interest, but positions should be scrutinized for price movement confirmation before executing trades.

The recent developments serve as potential catalysts for AQST, particularly the FDA’s decision not to require an advisory committee for Anaphylm’s approval, boosting the stock by as much as 43.77% in recent days. This regulatory progress aligns with positive analyst sentiment, exemplified by Oppenheimer’s revised target of $8 and maintaining an ‘Outperform’ rating. Compared to healthcare benchmarks, AQST exhibits higher volatility yet promises significant upside contingent on product development outcomes. Investors should monitor the management’s execution on Anaphylm’s launch, as January 31, 2026, PDUFA date approaches, indicating potential for further price appreciation towards set price targets while considering investor sentiment and broader market conditions.

  • A substantial uptick in share price was observed as analysts, including Oppenheimer, raised the price target from $7 to $8 and maintained an Outperform rating. This reflects increased confidence in the company’s growth potential in light of recent regulatory gains.

  • Shares saw a dramatic rise of 43.77% following the FDA’s communication, illustrating a strong market response to streamlined approval procedures that bypass a typically lengthy committee review process.

  • LifeSci Capital, another significant player, has also initiated coverage on Aquestive Therapeutics with an Outperform rating and a projected price target of $10, further solidifying bullish market projections for the company’s future performance.

Candlestick Chart

More Breaking News

Weekly Update Sep 15 – Sep 19, 2025: On Sunday, September 21, 2025 Aquestive Therapeutics Inc. stock [NASDAQ: AQST] is trending up by 15.34%! Discover the key drivers behind this movement as well as our expert analysis in the detailed breakdown below.

Quick Financial Overview

Recent financial statements reveal a complex picture of Aquestive Therapeutics’ fiscal health as the approval process progresses. Though the company’s latest quarter revealed a consistent revenue stream at $57.56M, various factors highlight financial vulnerabilities. The company faces negative profitability metrics, with key margins like EBIT and EBITDA deeply in the red at -130.8% and -111.1% respectively. This stark profitability profile underscores the necessity for accelerated growth or drastic margin improvement.

Simultaneously, both income statements and valuations signal skeptical investor sentiment due to a high price-to-sales ratio of 12.81, reflecting expectations of significant revenue expansion often seen in biotech firms poised for breakthrough product launches. Despite this optimism, the debt-ridden balance sheet features a formidable total debt-to-equity challenge, a factor that warrants caution until revenues grow to effectively leverage these liabilities.

From a performance perspective, stock volatility has shifted dramatically, with prices ranging from a low of $4.87 to a peak of $5.67 within a few days, fueled by newly reinvigorated investor interest and favorable regulatory outcomes. Looking at cash flow patterns noted in recent financial disclosures, there’s a material emphasis on strategic capital deployment to scale operations in anticipation of Anaphylm’s eventual market entry, envisioning substantial future cash inflows to balance persistent outflows and current leverage concerns.

Conclusion

Aquestive Therapeutics stands at the cusp of a promising yet challenging regulatory landscape, with recent FDA developments providing a much-needed tailwind. While financial figures point to significant operational headroom for improvement, upcoming strategic initiatives around Anaphylm may unlock substantial value and enhance profitability profiles. As trader confidence builds, it’s worth remembering the advice of Tim Bohen, lead trainer with StocksToTrade: “I focus on what a stock is doing, not what I want it to do. Let the stock prove itself before you make a move.” The stock’s near-term trajectory hinges on effectively capitalizing on regulatory momentum to deliver on market expectations, marking a crucial period of transition for the company’s future trajectory.

This is stock news, not investment advice. StocksToTrade News delivers real-time stock market updates tailored to highlight the key catalysts driving short-term price movements. Our coverage is designed for active traders and investors who thrive in fast-moving markets, with a focus on volatile sectors like penny stocks, AI stocks, Robinhood stocks and other momentum plays. From earnings reports and FDA approvals to mergers, new contracts, and unusual trading volume, we break down the events that can spark significant price action.

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