原始来源记录
重大PDUFA 日期确定
Nuvation Bio：FDA为IBTROZI sNDA设定2027年1月4日目标行动日期
FDA接受了IBTROZI的sNDA，并附带TRUST-I和TRUST-II的更新疗效数据。FDA指定PDUFA目标行动日期为2027年1月4日。该申报包含额外10个月的随访数据，显示在TKI初治和TKI预处理ROS1+ NSCLC人群中均有持久缓解。
关键事实
- 申报时间
- 2026年8月6日 11:30
- 事件
- PDUFA 日期确定
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2027年1月4日
- TKI初治TRUST-I中位缓解持续时间
- 49.7个月
- TKI初治TRUST-I中位无进展生存期
- 49.6个月
- TKI预处理TRUST-II中位缓解持续时间
- 19.4个月
来源摘录
EX-99.1 2 d261840dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update Achieved $31.7 million in second quarter 2026 total revenue, including $23.2 million in net product revenue for IBTROZI ® (taletrectinib) IBTROZI is the most prescribed ROS1 TKI in in both first-line and overall new patient starts in 2026 based on IQVIA claims from first five months of the year ~85% of the approximately 160 new patients were TKI-naïve, representing QoQ growth of ~30% in this setting Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma Robust balance sheet with cash, cash equivalents, and marketable securities of $661.0 m