(RTTNews) - Organogenesis Holdings Inc. (ORGO) has completed its rolling BLA submission to the U.S. FDA for ReNu, a cryopreserved amniotic suspension allograft being developed for the management of symptomatic knee osteoarthritis (OA). The company said the filing marks a major regulatory milestone for a therapy aimed at millions of patients living with chronic knee pain.
The rolling submission began in December 2025 with non-clinical modules and is now complete following the submission of clinical and CMC (chemistry, manufacturing and controls) components. Organogenesis noted that it looks forward to continued engagement with the FDA during the review process.
Knee OA affects an estimated 31.1 million Americans, a number projected to rise to 34.4 million by 2027, and is one of the leading causes of disability and reduced quality of life. Many patients ultimately progress to total knee replacement when other treatment options no longer provide relief.
ReNu contains amniotic fluid cells and micronized amniotic membrane, offering cellular, growth factor, and extracellular matrix components.
The therapy has been evaluated in three large randomized controlled trials involving more than 1,300 patients and previously received FDA RMAT designation for knee OA in 2021. It was also commercially available for about six years under Section 361 of the Public Health Service Act.
Organogenesis said it remains confident in its regulatory progress and will continue working closely with the FDA as the agency reviews the application.
ORGO has traded between $2.21 and $7.07 over the past year. The stock closed Tuesday's trading at $2.40, up 0.42%. During overnight trading, the stock was at $2.44, up 1.67%.
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