AQST 最新10-Q变化
将 AQST 最新的定期申报(10-K/10-Q)与上一份同类型申报逐章节对比:每个章节新增/删除的段落数与原文摘录。全部为确定性文本对比——无相似度评分、无方向判断、非投资建议。
对比:10-Q · 2026-08-11 与上一份 10-Q · 2026-05-13
| 章节 | 结果 | 新增 | 删除 | 微调 | 未变 |
|---|---|---|---|---|---|
| 管理层讨论与分析 | 文字有新增/删除 | +56 | −30 | ~27 | 64 |
| 市场风险(第3项) | 无段落级文字变化 | 0 | 0 | 0 | 1 |
| 控制与程序 | 文字有新增/删除 | 0 | 0 | ~1 | 3 |
| 法律诉讼 | 文字有新增/删除 | 0 | 0 | ~1 | 0 |
| 风险因素 | 文字有新增/删除 | 0 | −7 | ~1 | 0 |
计数单位为段落;"新增/删除"指相对上一份文件新增/删除的文字,不含方向或好坏判断。
未列出(无法可靠提取或缺失):其他信息
代表性摘录
每个章节最多 5 条、每条约 300 字符的原文摘录,直接来自两份 SEC 文件。
管理层讨论与分析
相对上期新增的文字 · 来源: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…
相对上期删除的文字 · 来源: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…
风险因素
相对上期删除的文字 · 来源: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…
如何读 10-Q 的风险因素(第 1A 项)
10-Q 的风险因素章节有三种常见形态,本页按其一分类展示:
- 指向(pointer) — 公司仅声明"无重大变化"并指向年度 10-K 的完整风险因素;本季没有自己的风险文本可对比。
- 部分更新(partial) — 公司写明"除下述外无重大变化",只更新部分风险;摘录展示的正是本季新增的内容。
- 全文重述(restated) — 本季重新给出完整风险因素。若上一季只是"指向",则无法逐段对比,本页会将其标为"本季全文重述"。
这只是对文件结构的客观描述,不构成对风险高低的判断。
数据来自 SEC EDGAR 两份申报文件的文本级对比 · 确定性计算(无 AI 生成内容)· 仅供参考 · 非投资建议