AQST — what changed in the latest 10-Q
A section-by-section comparison of AQST's newest periodic SEC filing (10-K/10-Q) against the prior same-form filing: paragraphs added and removed per section, with verbatim excerpts. Purely a deterministic text diff — no similarity scores, no directional read, not investment advice.
Comparing 10-Q · 2026-08-11 vs the prior 10-Q · 2026-05-13
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +56 | −30 | ~27 | 64 |
| Market risk (Item 3) | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Controls & procedures | Text added/removed | 0 | 0 | ~1 | 3 |
| Legal proceedings | Text added/removed | 0 | 0 | ~1 | 0 |
| Risk factors | Text added/removed | 0 | −7 | ~1 | 0 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Not shown (absent or not faithfully extractable): Other information
Representative excerpts
Up to 5 excerpts of about 300 characters per section, quoted verbatim from the two SEC filings.
MD&A
Text added vs the prior filing · source: 10-Q · 2026-08-11
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not lim…
advancing Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine) topical gel for various potential dermatological conditions.
We manufacture licensed products at our facilities and anticipate that our current manufacturing capacity is sufficient for commercial quantities of our licensed products and product candidates currently in development. Our facilities have been inspected by the FDA, TGA, and DEA, and are subject to …
On January 30, 2026, the Company received a CRL that focused on administration and labeling guidance. Clinical trial results submitted as part of the NDA regarding comparability to approved auto-injectors (such as EpiPen and Auvi-Q), such as bracketing, repeat dose, and sustainability, were not ques…
On August 10, 2026, the Company announced results from its recent HF validation study and PK study for Anaphylm. The new HF study evaluated a revised packaging design, incorporating modifications to the pouch opening, instructions for use, and pouch and carton labeling intended to address previously…
Text removed vs the prior filing · source: 10-Q · 2026-05-13
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not lim…
We manufacture licensed products at our facilities and anticipate that our current manufacturing capacity is sufficient for commercial quantities of our licensed products and product candidates currently in development. Our facilities have been inspected by the FDA, TGA, and DEA, and are subject to …
EMA. Not all collaborative or licensed products of the Company that may be commercially launched in the future will necessarily be manufactured by us.
On January 30, 2026, the Company received a CRL that focused on administration and labeling guidance. The FDA cited deficiencies in the Anaphylm HF validation study. These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could ca…
On March 30, 2026, the Company announced the receipt of preliminary comments and completion of an in-person Type A meeting with the FDA regarding the resubmission of the Company's NDA for Anaphylm. The Company continues to plan for resubmission of the NDA in the third quarter of 2026, subject to com…
Risk factors
Text removed vs the prior filing · source: 10-Q · 2026-05-13
We rely on third parties to manufacture API for our licensed products and product candidates, and we intend to rely on third parties to manufacture the API for other approved products. The commercialization of any of our licensed products and product candidates, if approved, could be stopped, delaye…
We currently rely, and expect to continue to rely, on third parties to manufacture API for our licensed products and our product candidates, and control only certain aspects of their activities.
Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it could delay our supply of licensed products, proprietary product candidate programs and commercialization activities. Our reliance on these third parties reduces our …
The facilities used by us, and by our third-party API manufacturers, to manufacture our licensed products and product candidates must maintain a compliance status acceptable to the FDA or other applicable regulatory authorities pursuant to inspections that will be conducted after we submit our NDA t…
More generally, we and our API manufacturers of pharmaceutical products, may often encounter difficulties in production, particularly in scaling up and validating initial production. These problems include difficulties with production costs and yields, quality control, including stability of the pro…
How to read Risk Factors (Item 1A) in a 10-Q
A 10-Q risk-factor section usually takes one of three forms; this page classifies it as one of:
- Pointer — the filer states there have been no material changes and points back to the annual 10-K risk factors; there is no own risk text to compare this quarter.
- Partial update — the filer carves out specific updated risks ("except as set forth below"); the excerpts show exactly what is new this quarter.
- Restated in full — the quarter carries the complete risk-factor text. When the prior quarter was only a pointer there is no prior full text to diff against, so the page flags the section as restated instead.
This describes the filing structure only — it is never a judgement on whether risk went up or down.
Source: text-level diff of the two SEC EDGAR filings · deterministic (no AI-generated content) · for reference only · not investment advice