原始来源记录
决策级顶线结果
Organogenesis：第二项3期ReNu试验未达到主要终点
ReNu在膝骨关节炎中的第二项3期随机对照试验未达到其主要终点，即在六个月时疼痛较生理盐水有统计学意义的减轻。尽管未达到主要终点，ReNu在基线疼痛减轻方面较第一项3期试验显示出数值改善，且功能维持具有统计学意义（p<0.0001）。公司将于10月底前向FDA申请pre-BLA会议，讨论将两项3期研究的疗效数据合并分析以支持BLA申报。
关键事实
来源摘录
EX-99.1 2 d870311dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Organogenesis Provides Update on Second Phase 3 ReNu ® Study Company maintains confidence in ReNu as innovative pain management therapy • Second Phase 3 trial demonstrates numerical improvement in baseline pain reduction over the first Phase 3 trial despite not meeting the primary endpoint • Statistically significant maintenance of function (p<0.0001) • Company will request pre-BLA meeting with FDA to discuss submission pathway CANTON, Mass., September 25, 2025 (GLOBE NEWSWIRE) – Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today annou