Organogenesis Secures FDA Review For ReNu In Knee Osteoarthritis

Organogenesis Holdings said the U.S. FDA accepted its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft for pain management in symptomatic knee osteoarthritis. FDA acceptance is a meaningful regulatory milestone for the therapy’s review process, which should be supportive for sentiment around ORGO’s product development.

Analysis

Organogenesis Holdings said the U.S. FDA accepted its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft for pain management in symptomatic knee osteoarthritis. FDA acceptance is a meaningful regulatory milestone for the therapy’s review process, which should be supportive for sentiment around ORGO’s product development.