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APR 24 2027
UPCOMING · 267 DAYS TO PDUFA

Organogenesis Holdings ReNu (cryopreserved amniotic suspension allograft) $ORGO

for management of pain in symptomatic knee osteoarthritis

BLA · Standard Review

Accepted JUL 6 2026.

About

Knee osteoarthritis is a degenerative joint disease that causes progressive cartilage loss, bone changes, and inflammation, making it a leading cause of disability in adults. ReNu is a cryopreserved amniotic suspension allograft injected directly into the knee joint. This therapy may help manage pain by delivering a mix of biological components to the arthritic environment, potentially offering an alternative to purely symptomatic treatments.

Pivotal trial

NCT04636229 Phase 3 completed NCT04636229

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Source: ClinicalTrials.gov

Also in development