原始来源记录
重大申请已提交
Monopar 启动 ALXN1840 治疗 Wilson 病的滚动 NDA 提交
Monopar 于 2026 年 7 月 22 日开始向 FDA 提交 ALXN1840 的滚动 NDA。FDA 于 2026 年 6 月 30 日授予罕见儿科疾病认定，批准后可能使公司获得优先审评券。公司预计将在未来几个月内完成 NDA 提交。
关键事实
- 申报时间
- 2026年8月12日 13:30
- 事件
- 申请已提交
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 ex_1003235.htm EXHIBIT 99.1 ex_1003235.htm Exhibit 99.1 Monopar Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates Wilmette, IL, August 12, 2026 – Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced second quarter 2026 financial results and provided business updates. Recent Program Developments ALXN1840 for Wilson Disease – Rolling NDA Submission Initiated On July 22, 2026, Monopar announced it had initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALXN1840. The FDA authorized Monopar to submit the NDA on a rolling basis, a