The March 16, 2027 PDUFA date is the next binary catalyst. Monitor for any FDA advisory committee meeting announcement or additional information requests during the review cycle. The Class 2 classification (6-month review) is standard for complete responses and does not imply a more complex review than typical.
Price Chart
Executive Summary
Aquestive Therapeutics announced FDA acceptance of its resubmitted NDA for Anaphylm (dibutepinephrine) sublingual film as a Class 2 response, with a PDUFA goal date of March 16, 2027. This provides a clear regulatory timeline for the potential first oral rescue medication for anaphylaxis, though the Class 2 classification implies a standard 6-month review cycle. The company also continues ex-U.S. regulatory progress with a planned Canadian NDS in Q4 2026.
Key Facts
- FDA accepted Anaphylm NDA resubmission as complete, classified as Class 2 response
- PDUFA goal date set for March 16, 2027
- Resubmission submitted September 16, 2026, following positive human factors and PK studies addressing CRL items
- If approved, Anaphylm would be first and only oral rescue medication for severe allergic reactions including anaphylaxis
- Ex-U.S. strategy on track with Canadian NDS planned for Q4 2026
- Company advancing commercial preparations for potential launch
Financial Impact
First-to-market oral epinephrine rescue product for anaphylaxis; potential multi-hundred-million-dollar peak sales opportunity if approved. No specific revenue estimates provided.
Risk Factors
- FDA may still identify deficiencies during review or request additional studies
- Class 2 review does not guarantee approval; CRL risk remains
- Competitive landscape may evolve before potential 2027 launch
- Commercial execution risk if approved, as this would be Aquestive's first proprietary product launch
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3381477 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 11d ago | 8-K | $4.06 $4.13 | ▲ +1.72% | ▲ +2.74% | $4.00 (−1.48%) |
Oct 15, 2026 11d ago | Press Release | $4.06 $4.13 | ▲ +1.72% | ▲ +2.74% | $4.00 (−1.48%) |
Oct 14, 2026 12d ago | 8-K | $4.61 $4.08 | ▼ −11.50% | ▼ −11.95% | $4.00 (−13.23%) |
Oct 7, 2026 19d ago | SC 13G | $4.62 $4.61 | ▼ −0.22% | ▲ +0.76% | $4.00 (−13.42%) |
Oct 7, 2026 19d ago | SC 13G/A | $4.62 $4.61 | ▲ +0.22% | ▼ −0.76% | $4.00 (+13.42%) |
Sep 29, 2026 27d ago | 8-K | $4.67 $4.61 | ▼ −1.28% | ▼ −3.23% | $4.00 (−14.35%) |
Sep 25, 2026 4w ago | 8-K | $4.68 $4.55 | ▼ −2.78% | ▼ −2.56% | $4.00 (−14.53%) |
Sep 17, 2026 5w ago | 8-K | $4.66 $4.82 | ▲ +3.43% | ▲ +2.83% | $4.00 (−14.16%) |
Sep 16, 2026 5w ago | Insider Cluster | $4.82 $4.70 | ▼ −2.49% | ▼ −5.05% | $4.00 (−17.01%) |
Aug 15, 2026 10w ago | Institutional Cluster | $4.29 $4.80 | ▲ +11.89% | ▲ +13.08% | $4.00 (−6.76%) |
US Market Status
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