The PDUFA date of March 16, 2027, provides a clear binary catalyst. Monitor for any FDA advisory committee meeting announcements or additional data requests ahead of the goal date. The Canadian NDS filing in Q4 2026 is a secondary near-term milestone.
Price Chart
Executive Summary
Aquestive Therapeutics announced that the FDA has accepted its resubmission of the New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, as complete and assigned a PDUFA goal date of March 16, 2027. The resubmission was classified as a Class 2 response, and the company remains on track to file a New Drug Submission with Health Canada in Q4 2026.
Key Facts
- FDA accepted Anaphylm NDA resubmission as complete and classified it as a Class 2 response
- PDUFA goal date set for March 16, 2027
- Resubmission was submitted on September 16, 2026, following positive topline results from human factors and PK studies
- Ex-U.S. strategy on track with Canadian NDS planned for Q4 2026
- If approved, Anaphylm would be the first and only oral rescue medication for severe allergic reactions, including anaphylaxis
Financial Impact
No financial figures provided; potential revenue from first-in-class oral epinephrine rescue product if approved
Risk Factors
- FDA may disagree with the Company's interpretation of study results or request additional studies
- Risk of a second Complete Response Letter if deficiencies are not fully addressed
- Class 2 review cycle is 6 months, but FDA could extend the review period
- Commercial launch depends on final FDA approval and proprietary name approval
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001398733-26-000058 |
| Document: a2026-10x19aquestivepduf.htm | 0001398733-26-000058 |
| Document: 0001398733-26-000058-index-headers.html | 0001398733-26-000058 |
| Document: 0001398733-26-000058-index.html | 0001398733-26-000058 |
| Document: 0001398733-26-000058.txt | 0001398733-26-000058 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 11d ago | 8-K | $4.06 $4.13 | ▲ +1.72% | ▲ +2.74% | $3.97 (−2.22%) |
Oct 15, 2026 11d ago | Press Release | $4.06 $4.13 | ▲ +1.72% | ▲ +2.74% | $3.97 (−2.22%) |
Oct 14, 2026 12d ago | 8-K | $4.61 $4.08 | ▼ −11.50% | ▼ −11.95% | $3.97 (−13.88%) |
Oct 7, 2026 19d ago | SC 13G | $4.62 $4.61 | ▼ −0.22% | ▲ +0.76% | $3.97 (−14.07%) |
Oct 7, 2026 19d ago | SC 13G/A | $4.62 $4.61 | ▲ +0.22% | ▼ −0.76% | $3.97 (+14.07%) |
Sep 29, 2026 27d ago | 8-K | $4.67 $4.61 | ▼ −1.28% | ▼ −3.23% | $3.97 (−14.99%) |
Sep 25, 2026 4w ago | 8-K | $4.68 $4.55 | ▼ −2.78% | ▼ −2.56% | $3.97 (−15.17%) |
Sep 17, 2026 5w ago | 8-K | $4.66 $4.82 | ▲ +3.43% | ▲ +2.83% | $3.97 (−14.81%) |
Sep 16, 2026 5w ago | Insider Cluster | $4.82 $4.70 | ▼ −2.49% | ▼ −5.05% | $3.97 (−17.63%) |
Aug 15, 2026 10w ago | Institutional Cluster | $4.29 $4.80 | ▲ +11.89% | ▲ +13.08% | $3.97 (−7.46%) |
US Market Status
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