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Axogen Provides Update on FDA Review Timeline for Avance Nerve Graft
FDA PDUFA goal date extended by three months ALACHUA, Fla. and TAMPA, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (Nasdaq: AXGN) today announced that
About this update from Axogen, Inc.
[{"type":"text","content":"FDA PDUFA goal date extended by three months\nALACHUA, Fla. and TAMPA, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (Nasdaq: AXGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for Avance® Nerve Graft by three months to December 5, 2025. On August 22, 2025, the Company received a communication from the FDA indicating that the information submitted by the Company in response to an FDA information request, which included substantial new manufacturing and facility data not previously reviewed by the Agency, was deemed a Major Amendment to its BLA. Under FDA guidelines, this designation allows for additional time to review the submission. As a result, the FDA has extended the PDUFA goal date to December 5, 2025. The FDA also informed the Company that it now anticipates providing feedback on product labeling in November 2025, consistent with PDUFA review procedures. “We appreciate the FDA's thorough review and look forward to continuing our engagement with the agency to complete the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic,” said Michael Dale, Axogen’s Chief Executive Officer. About Axogen Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries by providing innovative, clinically proven and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. Axogen’s product portfolio includes Avance® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second ...