Wave Life Sciences: FDA 接受 WVE-007 的 Phase 2a INLIGHT

FDA 已接受 INLIGHT 试验中 WVE-007 的 Phase 2a 多剂量部分，该试验针对 BMI 35-50 kg/m² 的个体，无论是否患有 type 2 diabetes。该安慰剂对照研究计划于 Q2 2026 启动，将评估 body composition、liver fat、HbA1c 及其他 cardiometabolic biomarkers，持续 12 months。

关键事实

申报时间: 2026年4月28日 11:34
事件: 申请已受理
方向: 积极
公司: WVEWave Life Sciences
资产: WVE-007
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 d135689dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Wave Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Update With recent FDA acceptance of the Phase 2a multidose portion of INLIGHT trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with higher BMI, with and without type 2 diabetes, this portion of the trial remains on track to initiate in 2Q 2026 Combination and maintenance trials of WVE-007 on track to initiate in 2026 Data from RestorAATion-2 trial of WVE-006 (GalNAc-RNA editing) in AATD (including 400 mg monthly dose and 600 mg single dose cohorts) to be presented at an investor webcast during the ATS International Conference in May 2026 Regulatory feedback on accelerated approval pathway for WVE-006 continues to be expected mid-2026 CTA su

SEC 8-K