Monitor progress on Anaphylm resubmission, including the Type A meeting with the FDA and completion of human factors and PK studies. The RTW financing alleviates near-term cash concerns but introduces potential dilution. The stock reaction will likely hinge on execution of the revised Anaphylm timeline and 2026 financial performance against guidance.
Price Chart
Executive Summary
Aquestive Therapeutics reported Q4 and full-year 2025 financial results, received a Complete Response Letter (CRL) from the FDA for its Anaphylm NDA due to human factors and packaging issues, and secured additional funding through a warrant issuance and committed equity purchase with RTW Investments. The company reaffirmed its plan to resubmit the NDA in Q3 2026 and extended its revenue-sharing agreement with RTW to June 2027.
Key Financial Metrics
Key Facts
- FDA issued a Complete Response Letter (CRL) for Anaphylm NDA on January 30, 2026, citing human factors validation issues (pouch opening, film placement) and requesting a PK study; no CMC or clinical deficiencies were noted.
- Company plans to resubmit Anaphylm NDA in Q3 2026 after completing required studies and holding a Type A meeting with the FDA.
- Entered into agreements with RTW Investments: extended marketing approval deadline to June 30, 2027, issued a warrant for 375,000 shares at $4.00 exercise price, and secured a $5 million committed equity purchase.
- Q4 2025 revenue increased 10% YoY to $13.0 million, driven by manufacturing and supply revenue; full-year 2025 revenue was $44.5 million, down 3% YoY excluding prior-year deferred revenue.
- Ended 2025 with $121.2 million in cash; guides to end 2026 with $70 million in cash.
- Full-year 2025 GAAP net loss was $83.8 million, or $0.78 per share, compared to $44.1 million, or $0.51 per share, in 2024.
Financial Impact
Revenue increased 10% in Q4 2025 to $13.0 million but declined 3% for the full year to $44.5 million. Net loss widened to $83.8 million for 2025 from $44.1 million in 2024. The RTW financing provides up to $5 million in committed equity and a warrant for 375,000 shares.
Segment Breakdown
| Segment | Revenue | Growth |
|---|---|---|
| Manufacture and supply | $40.2M | +0.5% |
Risk Factors
- Failure to resolve FDA's human factors concerns could delay or prevent Anaphylm approval.
- The $5 million equity commitment from RTW may lead to dilution if shares are issued at a discount to market price.
- Continued net losses and cash burn could pressure the balance sheet if Anaphylm approval is further delayed.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 10 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001398733-26-000016 |
| Document: formofaquestive2026warra.htm | 0001398733-26-000016 |
| Document: aqst-20260303.htm | 0001398733-26-000016 |
| Document: q42025supplementalearnin.htm | 0001398733-26-000016 |
| Document: equitycommitmentagreemen.htm | 0001398733-26-000016 |
| Document: warrantissuanceagreement.htm | 0001398733-26-000016 |
| Document: amdno1rtw-aqstxfeb2026ex.htm | 0001398733-26-000016 |
| Document: 0001398733-26-000016-index-headers.html | 0001398733-26-000016 |
| Document: 0001398733-26-000016-index.html | 0001398733-26-000016 |
| Document: 0001398733-26-000016.txt | 0001398733-26-000016 |
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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