GlobeNewswire·Jul 6, 2026, 4:05 PM ET

Organogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis

Organogenesis Holdings Inc. (NASDAQ: ORGO) announced that the FDA has accepted its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft for treating knee osteoarthritis pain.
The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.
ReNu consists of amniotic fluid cells & micronized amniotic membrane containing cellular, growth factor, & extracellular matrix components.
The product was studied in three large randomized controlled trials involving over 1,300 patients & received FDA RMAT designation in 2021.
The FDA has conditionally accepted "Amnuvx" (azimplacel) as the proprietary name for ReNu pending final approval.
Knee osteoarthritis currently affects nearly 31 million Americans & is projected to exceed 34 million by 2027.
Patrick Bilbo, Chief Operating Officer, stated the acceptance brings the company closer to providing the first non-surgical biologic therapy for this condition.
The press release includes standard forward-looking statements regarding clinical development risks, regulatory approval timing, reimbursement uncertainty, & manufacturing capabilities.