AQST Soars 28% on FDA Green Light: A Game-Changer in Allergy Treatment?

Summary
• Aquestive Therapeutics (AQST) surges 28.23% intraday to $5.065, defying a 52-week low of $2.12.
• FDA confirms no advisory committee meeting for Anaphylm™ NDA, with PDUFA target set for January 31, 2026.
• $160 million in recent financing fuels commercial readiness for the first sublingual epinephrine film.

Aquestive Therapeutics (AQST) is scripting a dramatic turnaround as its stock soars 28.23% in a single trading session, fueled by regulatory clarity and robust clinical data. The FDA’s decision to bypass an advisory committee for Anaphylm™’s NDA has ignited investor optimism, positioning the stock at a critical inflection point. With a 52-week high of $5.80 still in reach, the market is betting on a potential first-in-class approval for a needle-free allergy treatment.

FDA’s Green Light Ignites Bullish Sentiment
Aquestive’s 28.23% surge is directly tied to the FDA’s confirmation that Anaphylm™ (dibutepinephrine) Sublingual Film will not require an advisory committee meeting. This regulatory shortcut signals the agency’s confidence in the product’s safety and efficacy, as evidenced by 967 administrations across 11 clinical studies. The absence of contentious safety debates removes a major hurdle, accelerating the PDUFA timeline to January 31, 2026. Additionally, the company’s $160 million in recent financing underscores its readiness to commercialize the product post-approval, addressing a $1.2 billion epinephrine market dominated by injectable options.

Options Playbook: Capitalizing on AQST’s Volatility
• 200-day average: 3.3728 (below current price); RSI: 47.27 (neutral); MACD: -0.0079 (bearish signal); Bollinger Bands: 4.1464 (upper), 3.9240 (middle), 3.7016 (lower).
• Kline pattern: Short-term bullish trend; Support/Resistance: 4.1032–4.1130 (30D), 3.8076–3.8664 (200D).

AQST’s technicals suggest a breakout from a long-term trading range, supported by elevated volume (9.82% turnover rate). The stock is testing its 52-week high of $5.80, with key resistance at $5.09 (intraday high). For traders, the AQST20250919C5 call option (strike $5, expiration 9/19) stands out: it offers a 700% price change ratio, 12.62% leverage, and 88.27% implied volatility. With a delta of 0.562 and theta of -0.0179, it balances sensitivity to price moves with time decay. A 5% upside to $5.315 would yield a payoff of $0.315 per share. Meanwhile, the AQST20251121C5 (strike $5, expiration 11/21) provides a 156.76% price change ratio and 5.32% leverage, ideal for a longer-term bullish bet. Both contracts benefit from high turnover (43,552 and 61,116 shares) and moderate gamma (0.422 and 0.167), ensuring liquidity and responsiveness to price swings. Aggressive bulls should target a breakout above $5.09, with a stop-loss near $4.24 (intraday low).

Backtest Aquestive Stock Performance

AQST’s PDUFA Countdown: A High-Stakes Regulatory Race
Aquestive’s 28.23% rally hinges on its ability to maintain momentum ahead of the January 31, 2026 PDUFA date. The stock’s technicals and options activity suggest a bullish consensus, but risks remain: a breakdown below $4.24 could trigger a retest of the 52-week low. Meanwhile, sector leader Johnson & Johnson (JNJ) fell 0.05%, underscoring the sector’s mixed performance. Investors should monitor AQST’s 200-day average ($3.37) and the $5.09 intraday high as critical levels. For those with a high-risk appetite, the AQST20250919C5 offers a leveraged play on a potential regulatory win, but caution is warranted if the stock fails to hold above $4.50. The next 45 days will be pivotal—watch for FDA feedback or clinical data updates to validate the market’s optimism.