The key catalyst is the FDA's classification and review timeline for the Anaphylm NDA resubmission, which will determine the PDUFA goal date. Monitor for FDA acceptance of the resubmission and any decision on the requested expedited review, as this will set the stage for a potential approval decision and the release of contingent funding.
Price Chart
Executive Summary
Aquestive Therapeutics filed an 8-K with an investor presentation on September 23, 2026, highlighting the NDA resubmission for Anaphylm (dibutepinephrine) sublingual film on September 17, 2026, after a CRL on January 30, 2026. The presentation also outlines a $98.5M cash position, access to $95M in contingent funding upon FDA approval, and pipeline progress for AQST-108 topical gel in atopic dermatitis.
Key Facts
- NDA for Anaphylm (dibutepinephrine) sublingual film resubmitted to FDA on September 17, 2026, after receiving a Complete Response Letter (CRL) on January 30, 2026.
- Cash and cash equivalents of $98.5 million as of June 30, 2026.
- Access to $75 million from RTW Investments and $20 million from Oaktree Capital Management, both contingent on FDA approval of Anaphylm.
- Potential peak annual net sales of >$1B for Anaphylm, >$500M for AQST-108, and >$100M for Libervant.
- Ex-US filing for Anaphylm planned in Canada before end of 2026 and in the EU in Q1 2027.
- AQST-108 (epinephrine) topical gel is pursuing atopic dermatitis as an initial indication, with potential for additional dermatologic and immunologic indications.
Financial Impact
Cash position of $98.5M; up to $95M in contingent funding upon FDA approval of Anaphylm; potential peak annual net sales of >$1B for Anaphylm, >$500M for AQST-108, and >$100M for Libervant.
Risk Factors
- FDA may determine the NDA resubmission is not a complete response to the CRL, refuse to file, or classify it differently, leading to a longer review period.
- Expedited review may not be granted, extending the timeline to a potential approval decision.
- Contingent funding of up to $95M is dependent on FDA approval of Anaphylm; failure to secure approval would leave the company with its current cash position only.
- Clinical and regulatory risks for AQST-108 in atopic dermatitis, including potential failure in future trials or inability to secure regulatory approval.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001398733-26-000048 |
| Document: aqst-20260923.htm | 0001398733-26-000048 |
| Document: 0001398733-26-000048-index-headers.html | 0001398733-26-000048 |
| Document: 0001398733-26-000048-index.html | 0001398733-26-000048 |
| Document: 0001398733-26-000048.txt | 0001398733-26-000048 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | 8-K | $4.06 $4.13 | ▲ +1.72% | ▲ +2.74% | $3.97 (−2.22%) |
Oct 15, 2026 12d ago | Press Release | $4.06 $4.13 | ▲ +1.72% | ▲ +2.74% | $3.97 (−2.22%) |
Oct 14, 2026 13d 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 28d 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
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers