Organogenesis Secures FDA Review For ReNu In Knee Osteoarthritis
(RTTNews) – Organogenesis Holdings Inc. (ORGO) announced that the U.S. FDA has accepted its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft designed to manage pain in patients with symptomatic knee osteoarthritis.
Knee osteoarthritis (OA) is a degenerative disease affecting nearly 31 million Americans, with projections rising to more than 34 million by 2027. It is one of the leading causes of disability, often culminating in total knee replacement when other treatments fail.
ReNu combines amniotic fluid cells and micronized amniotic membrane, delivering cellular, growth factor, and extracellular matrix components. The therapy has been evaluated in three large randomized controlled trials involving over 1,300 patients and previously received FDA RMAT designation in 2021.
The FDA has set a PDUFA action date of April 24, 2027. Organogenesis noted that this milestone brings the company closer to offering what could be the first non-surgical biologic therapy for millions of Americans living with knee OA pain.
The FDA has also conditionally accepted “Amnuvx” (azimplacel) as the proprietary name for ReNu, pending final review and approval.
ORGO has traded between $2.04 and $7.07 over the past year. The stock closed Monday’s trading at $2.48, up 5.08%. During after-hours trading session, the stock is at $2.51, up 1.21%.
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