Organogenesis Holdings (NASDAQ: ORGO) has announced that the FDA has accepted for review its Biologics License Application (BLA) for ReNu, a cryopreserved, amniotic suspension allograft developed for the treatment of pain in symptomatic knee osteoarthritis (OA).
According to Organogenesis, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.
In a statement, Patrick Bilbo, COO of Organogenesis, commented, “We are pleased to reach this important milestone and look forward to working with the FDA as they complete their review. We are now one step closer to our goal of bringing the first non-surgical biologic therapy to the millions of Americans whose lives are impacted by knee OA pain.”
