原始出處紀錄
決策級PDUFA 日期確定
Replimune：RP1 針對抗 PD-1 失敗黑色素瘤的 PDUFA 日期定於 2026 年 4 月 10 日
JPM 2026 簡報指出，RP1 用於抗 PD-1 失敗黑色素瘤的 PDUFA 日期為 2026 年 4 月 10 日。公司表示其商業團隊已準備好上市，首日即有 150 個帳戶就緒。確認性 IGNYTE-3 試驗的招募進度符合預期，期中 OS 分析預計於 2027 年下半年進行。
關鍵事實
來源摘錄
EX-99.1 2 tm262890d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 © 2026 Replimune Group Inc. JPM 2026 Presentation Click to edit Master title style 1 Click to edit Master text styles Igniting a systemic immune response to cancer with oncolytic immunotherapy January 14, 2026 JPM Healthcare Conference © 2025 Replimune Group Inc. © 2026 Replimune Group Inc. 2 Safe harbor Any statements contained herein that are not statements of historical facts may be deemed to be forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the advancement, timing and sufficiency of our clinical trials or financial status, patient enrollments in our existing and planned