原始来源记录
决策级PDUFA 日期确定
Replimune：RP1在抗PD-1失败黑色素瘤中的PDUFA日期定于2026年4月10日
JPM 2026演示文稿显示，RP1在抗PD-1失败黑色素瘤中的PDUFA日期临近，为2026年4月10日。公司表示其商业团队已做好上市准备，第一天将有150个账户准备就绪。确证性IGNYTE-3试验入组进展顺利，计划在2027年下半年进行OS中期分析。
关键事实
来源摘录
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