Aquestive Secures $100M for Anaphylm Launch Following FDA Guidance

Aquestive Therapeutics is preparing for the U.S. commercial launch of its Anaphylm sublingual film. The company has secured $100 million in dedicated funding while finalizing regulatory requirements for the epinephrine product. It expects to resubmit its application to the FDA in the third quarter of 2024.

"The FDA told the company that the key clinical questions had been answered from an approval perspective," said Dan Barber, President and Chief Executive Officer of Aquestive, during the Cantor Healthcare Conference.

Launch Capital and Regulatory Timeline

The $100 million in committed capital supports the market entry of Anaphylm, an alternative to traditional injectable epinephrine for severe allergic reactions. This funding includes $75 million secured through a royalty strip with RTW Investments and a $20 million debt facility provided by Oaktree Capital.

Regarding the regulatory pathway, the company is aiming for a two-month Class 1 review cycle. Management noted that they are planning for a six-month Class 2 assignment, which would extend the timeline for a final decision.

Clinical Performance and Human Factors

Aquestive has focused on the usability of the sublingual film as part of its regulatory submission. In a recent human factors study, 100 participants were tasked with opening the Anaphylm pouch, removing the film, and administering the dose. The company reported that participants completed the process in an average of 17 seconds.

Financial Context

These developments occur as Aquestive manages its capital structure ahead of the potential launch. As of September 11, 2026, Aquestive Therapeutics (AQST) stock was trading at $4.90, which is a decline of 1.80% for the day.

For patients and healthcare providers, the stake involves the potential introduction of a non-invasive delivery method for epinephrine. By moving away from needle-based injectors, Aquestive aims to address barriers to treatment for patients experiencing anaphylaxis who may be hesitant to use traditional auto-injectors.