tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

Aquestive Therapeutics Awaits FDA Decision on Anaphylm

Story Highlights
  • Aquestive Therapeutics announced FDA’s decision not to require an advisory committee for Anaphylm.
  • Anaphylm could become the first non-invasive epinephrine product, impacting anaphylaxis treatment.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Aquestive Therapeutics Awaits FDA Decision on Anaphylm

Elevate Your Investing Strategy:

  • Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

Aquestive Therapeutics ( (AQST) ) has provided an announcement.

On September 4, 2025, Aquestive Therapeutics announced that the FDA will not require an advisory committee meeting for their new drug application for Anaphylm™, a sublingual film for severe allergic reactions. This decision keeps the Prescription Drug User Fee Act target action date on track for January 31, 2026, potentially making Anaphylm the first FDA-approved, non-invasive epinephrine product. The company is preparing for a rapid launch upon approval, supported by recent financing activities, which could significantly impact the treatment landscape for anaphylaxis by offering a needle-free alternative.

The most recent analyst rating on (AQST) stock is a Hold with a $4.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.

Spark’s Take on AQST Stock

According to Spark, TipRanks’ AI Analyst, AQST is a Neutral.

The overall stock score is primarily impacted by significant financial challenges, including declining revenues and high leverage. While technical indicators and valuation present moderate concerns, recent corporate events and earnings call insights offer some optimism for future growth, particularly with Anaphylm’s potential market impact.

To see Spark’s full report on AQST stock, click here.

More about Aquestive Therapeutics

Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies. They develop orally administered products to provide novel alternatives to invasive standard of care therapies. The company has four commercialized products marketed by its licensees globally and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies.

Average Trading Volume: 1,367,571

Technical Sentiment Signal: Strong Buy

Current Market Cap: $463.3M

Learn more about AQST stock on TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1