原始出處紀錄
重大申請已送件
Monopar 啟動 ALXN1840 治療威爾森氏症的滾動 NDA 申請
Monopar 於 2026 年 7 月 22 日開始向 FDA 提交 ALXN1840 的滾動 NDA。FDA 於 2026 年 6 月 30 日授予罕見兒科疾病認定，若獲批准，公司可能獲得優先審查憑證。公司預計將在未來幾個月內完成 NDA 提交。
關鍵事實
- 申報時間
- 2026年8月12日 下午01:30
- 事件
- 申請已送件
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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