Organogenesis Holdings Inc. (ORGO) announced the successful completion of a planned Type-B meeting with the U.S. FDA, confirming that the company may initiate a rolling Biologics License Application for ReNu in knee osteoarthritis pain.
Knee osteoarthritis (OA) is a degenerative joint disease affecting an estimated 31.1 million Americans, projected to rise to 34.4 million by 2027. It is among the most common causes of disability and reduced quality of life, with end-stage management typically requiring total knee replacement when other treatment options are exhausted.
ReNu is a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee OA. It consists of amniotic fluid cells and micronized amniotic membrane, containing cellular, growth factor, and extracellular matrix components.
The therapy has been studied in three large randomized controlled trials involving more than 1,300 patients and was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in 2021.
The FDA confirmed that the ReNu clinical development program, which includes two large Phase 3 randomized controlled trials (RCT), a separate 200-patient study, and extensive commercial history, is appropriate for BLA submission. Organogenesis expects to initiate the rolling BLA before the end of December 2025.
If approved, ReNu would represent a novel regenerative medicine option for millions of patients living with knee OA, addressing a significant unmet medical need.
ReNu was previously marketed under Section 361 of Public Health Service Act, which allowed limited commercial availability without a full FDA license. Following updated regulatory guidance, Organogenesis is now pursuing a BLA to secure long-term approval and reimbursement pathway.
ORGO has traded in the range of $2.61 to $7.07 over the past year. The stock closed yesterday's trading at $4.83, up 0.21%, and rose further in the overnight trading to $5.37, up 11.18%.
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