The FDA's classification of the resubmission (e.g., Class 1 vs Class 2 review) and the resulting PDUFA goal date will be the next major catalyst. A Class 1 review (2 months) would be highly bullish, while a Class 2 review (6 months) would push the decision to mid-2027. Monitor for FDA acceptance and classification announcement in the coming weeks.
Price Chart
Executive Summary
Aquestive Therapeutics announced the resubmission of its New Drug Application (NDA) to the FDA for Anaphylm (dibutepinephrine) sublingual film, following a Complete Response Letter (CRL) in January 2026. The resubmission is supported by positive human factors and pharmacokinetic study results that addressed FDA concerns regarding packaging and administration. The FDA will now determine the classification and review timeline for the resubmission.
Key Facts
- Aquestive resubmitted its NDA to the FDA for Anaphylm (dibutepinephrine) sublingual film on September 17, 2026.
- The resubmission addresses the FDA's Complete Response Letter (CRL) issued January 30, 2026, which requested a human factors study and a confirmatory PK study.
- The human factors study showed improvement: median pouch-opening time reduced from 17 seconds to 3 seconds; no protocol-defined use errors in the self-administration arm of the PK study.
- The company expects to file for marketing authorization in Canada before end of 2026 and in the EU in Q1 2027.
- Aquestive intends to request expedited FDA review of the resubmission (not guaranteed).
- The company estimates potential peak annual net sales of >$1B for Anaphylm and >$500M for AQST-108 (epinephrine topical gel).
Financial Impact
Potential peak annual net sales of >$1B for Anaphylm and >$500M for AQST-108, per company estimates. No current revenue or earnings figures reported in this filing.
Risk Factors
- FDA may determine the resubmission does not constitute a complete response to the CRL, or may refuse to file it.
- FDA may classify the resubmission as a Class 2 review, resulting in a longer 6-month review period.
- A citizen petition regarding Anaphylm was submitted to the FDA on October 1, 2025, which could impact the review.
- The company's ability to secure sufficient capital to fund commercialization if approved is not addressed in this filing.
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001398733-26-000044 |
| Document: aqst-20260914.htm | 0001398733-26-000044 |
| Document: ndapressrelease-9x14x202.htm | 0001398733-26-000044 |
| Document: 0001398733-26-000044-index-headers.html | 0001398733-26-000044 |
| Document: 0001398733-26-000044-index.html | 0001398733-26-000044 |
| Document: 0001398733-26-000044.txt | 0001398733-26-000044 |
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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