URGN 最新10-Q变化
将 URGN 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 · 2026-08-05 与上一份 10-Q · 2026-05-06
| 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 | +26 | −18 | ~19 | 90 |
| 市场风险(第3项) | 文字有新增/删除 | 0 | 0 | ~3 | 1 |
| 控制与程序 | 文字有新增/删除 | 0 | 0 | ~3 | 0 |
| 法律诉讼 | 文字有新增/删除 | +4 | −2 | 0 | 0 |
| 风险因素 | 部分风险因素更新 | +6 | −13 | ~35 | 470 |
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 · 2026-08-05
In March 2025, we announced 18-month DOR data from the Phase 3 ENVISION trial. The 18-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri remained consistent with the 12-month DOR data: 80.6% (95% CI, 74.0%, 85.7%) at 18-months (n…
Additionally, in July 2025 we announced outcomes from the five-year long-term extension study of the single-arm, Phase 2b OPTIMA II study. Among the 41 patients who achieved CR at three months post-treatment with Zusduri in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-…
In July 2026, we announced that we received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating recurrent low-grade intermediate risk NMIBC without TURBT, supported by data from the ENVISION and ATLAS clinical trials. Once issued, the pa…
Our future research and development expenses will depend on the clinical success of our product candidates. As we continue to focus on advancing our product candidates, we expect research and development expenses to continue to be significant.
The following table sets forth our results of operations for the three months ended June 30, 2026 and 2025.
相对上期删除的文字 · 来源:10-Q · 2026-05-06
In March 2025, we announced 18-month DOR data from the Phase 3 ENVISION trial. The 18-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri remained consistent with the 12-month DOR data: 80.6% (95% CI, 74.0%, 85.7%) at 18-months (n…
In August 2025, we announced 24-month DOR data from the Phase 3 ENVISION trial. The 24-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri was 72.2% (95% CI, 64.1%, 78.8%). Median follow-up time was 23.7 months after the three-mon…
Additionally, in July 2025 we announced outcomes from the five-year long-term extension study of the single-arm, Phase 2b OPTIMA II study. Among the 41 patients who achieved CR at three months post-treatment with Zusduri in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-…
We are currently focused on advancing our product candidates, and our future research and development expenses will depend on their clinical success. Research and development expenses will continue to be significant.
Comparison of the three months ended March 31, 2026 and 2025
法律诉讼
相对上期新增的文字 · 来源:10-Q · 2026-08-05
On April 2, 2024, we filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. (together with Teva Pharmaceuticals, Inc., "Teva"), and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9…
On June 2, 2026, we entered into a settlement and license agreement (the “Agreement”) with Teva, resolving this litigation. Under the Agreement, we have agreed to grant Teva a non-exclusive license to sell its generic version of Jelmyto beginning on September 15, 2030, if approved by the FDA, unless…
On June 3, 2026, the court granted the parties’ Stipulated Dismissal Order, dismissing and closing the civil action. As required by law, the parties submitted the Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review.
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any material legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, …
相对上期删除的文字 · 来源:10-Q · 2026-05-06
On April 2, 2024, the Company filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069 and seeking a perma…
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. Other than as set forth above, we are not currently a party to any material legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of…
风险因素
相对上期新增的文字 · 来源:10-Q · 2026-08-05
Our indebtedness resulting from our loan agreement with Pharmakon Advisors, L.P. ("Pharmakon") could adversely affect our financial condition or restrict our future operations.
Our projections of both the number of people who have the cancers we are targeting, as well as the subset of people with these cancers who have previously failed prior treatments, and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates…
Pursuant to our April 2026 supply agreement with TAPI NL B.V. ("TAPI"), we agreed to purchase from TAPI a specified, significant percentage of our commercial requirements for the mitomycin needed for our commercial products. If TAPI is unwilling or unable to supply us with our commercial requirement…
We seek patent protection for our approved products, product candidates, and proprietary technologies. We rely on a broad collection of intellectual property comprised of owned, co-owned, and in-licensed patents, patent applications, trade secrets, know-how, and trademarks. covering our proprietary …
We expect current and future legislation affecting the healthcare industry, including healthcare reform, to impact our business generally and to increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations, and/o…
相对上期删除的文字 · 来源:10-Q · 2026-05-06
Our indebtedness resulting from our loan agreement with Pharmakon Advisors, L.P. ("Pharmakon") could adversely affect our financial condition or restrict our future operations.
If the FDA concludes that the requirements for our relevant product candidates are not as we expect, the approval pathway for these product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in eith…
Our projections of both the number of people who have the cancers we are targeting, as well as the subset of people with these cancers who have previously failed prior treatments, and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates…
the FDA’s determination that the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act ("FDCA") regulatory pathway (“505(b)(2)”) is available for our product candidates;
We seek patent protection for our product candidates, and we hold a broad collection of intellectual property comprised of issued patents, in-licensed patents, pending patent applications, trade secrets and trademarks covering our proprietary RTGel technology, the pharmaceutical compositions, method…
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