原始来源记录
决策级顶线结果
Atea AVIR：C-BEYOND III期试验达到BEM/RZR治疗HCV的主要/次要终点
该文件报告，III期C-BEYOND试验在mITT人群中达到统计学非劣效于SOF/VEL的主要终点（SVR 93.9% vs 94.8%），并达到所有次要终点，包括符合方案集分析。非肝硬化患者接受8周BEM/RZR方案的SVR为93.5%，支持其潜在同类最佳特征：疗程更短、药物相互作用风险低且无食物影响。NDA提交时间现指引为2027年Q2，待C-FORWARD结果出炉后确定。
关键事实
- 申报时间
- 2026年8月12日 20:15
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- mitt N
- 905
- mITT人群SVR
- 93.9% vs 94.8%
- 肝硬化n
- 184
- 肝硬化患者SVR
- 95.4% vs 95.4%
- 非肝硬化n
- 721
- 非肝硬化患者SVR
- 93.5% vs 94.6%
- 非劣效性界值
- 5%
来源摘录
EX-99.1 2 d165663dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Atea Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Business Update Phase 3 C-BEYOND Trial Met Primary and Secondary Endpoints, with a Short 8-week Duration for Patients Without Cirrhosis Supporting a Potential Best-in-Class Profile of BEM/RZR for Treatment of HCV C-FORWARD Phase 3 Trial Outside North America on Track with Topline Results Expected Early Q1 2027 AT-587 Phase 1 Clinical Trial Advancing for Treatment of Hepatitis E Virus (HEV) Company Holding Conference Call Today at 4:30 pm ET BOSTON, Mass., August 12, 2026 – Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutic