ORGO 오가노제네시스

Organogenesis: 제2상 Phase 3 ReNu 시험, 1차 평가변수 미달

The second Phase 3 RCT of ReNu in knee OA did not meet its primary endpoint of statistically significant pain reduction versus saline at six months. Despite the miss, ReNu showed numerical improvement over the first Phase 3 trial and statistically significant maintenance of function (p<0.0001). The company will request a pre-BLA meeting with FDA by end of October to discuss a combined efficacy analysis from both Phase 3 studies to support a BLA submission.