Business UpdateSep 25, 2026, 08:05 AM
Aquestive Therapeutics Resubmits Anaphylm NDA to FDA
AI Summary
Aquestive Therapeutics, Inc. has filed an 8-K report detailing an investor presentation. The company announced the resubmission of its New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film to the FDA on September 17, 2026, following a Complete Response Letter (CRL) received earlier in the year. The presentation also highlights the company's pipeline, including AQST-108 for atopic dermatitis, and its financial position, with $98.5 million in cash and access to additional funding upon Anaphylm's potential FDA approval. Key product attributes and market opportunities for Anaphylm and AQST-108 are discussed.
Key Highlights
- Aquestive Therapeutics resubmitted NDA for Anaphylm (dibutepinephrine) sublingual film to FDA on September 17, 2026.
- Company has $98.5 million in cash and cash equivalents as of June 30, 2026.
- Access to $75 million available if Anaphylm is approved by the FDA through a Strategic funding agreement.
- An additional $20 million available under debt facility if Anaphylm is approved by the FDA.
- AQST-108 (epinephrine) topical gel is being pursued for atopic dermatitis and other dermatology indications.
- Anaphylm reaches peak absorption in 12 minutes, with therapeutic blood concentrations in as little as 5 minutes.
- 96% of survey respondents preferred Anaphylm over nasal spray in a hands-on epinephrine preference survey.
Price Impact
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