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.

핵심 사실

제출: 2025년 9월 25일 PM 09:00
이벤트: 탑라인 결과
방향: 중립
기업: ORGO오가노제네시스
자산: ReNu
출처: SEC 8-K
신뢰도: 출처 확인
WOMAC 통증 차이: -0.5(ReNu에 유리, p=0.0393 단측)
총 연구 대상 환자: 1,300명 초과
WOMAC 기능 유지: p<0.0001
기저치 대비 통증 감소(1차 3상): -6.0(ReNu) 대 -5.3(생리식염수)
기저치 대비 통증 감소(2차 3상): -6.9(ReNu) 대 -6.4(생리식염수)

출처 발췌

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

SEC 8-K