India, April 28 -- 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 ...