FDA Confirms Direct Review Path For Aquestive's Allergy Treatment

The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. (NASDAQ:AQST) that an advisory committee meeting is not required for Anaphylm (dibutepinephrine) Sublingual Film.

The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.

Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis.

Also Read: Developer Of EpiPen Alternative Aquestive Stock Undervalued Despite Strong Clinical Data, Analyst Sees Huge Upside

If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue.

Eleven clinical studies have been completed, with 967 administrations in total (840 single-dose and 127 repeat-dose) for adults and children over 30 kg. The development program also includes a novel trial for oral allergy syndrome demonstrating Anaphylm’s real-world effectiveness.

In April, Aquestive Therapeutics released topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing over 30 kgs with a personal history of allergic reactions.

Thirty-two patients completed the pediatric study. The PK results were consistent with previous adult studies. Anaphylm was safe and well-tolerated, and no serious adverse events were reported.

Equity research can be a valuable source of information for learning about a company’s fundamentals.

Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.

Shares of Aquestive Therapeutics have an average 1-year price target of $10.0, representing an expected upside of 110.3%.

Price Action: AQST stock is trading higher by 23.09% to $4.86 at last check Thursday.

FDA Confirms Direct Review Path For Aquestive’s Allergy Treatment

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