Axogen Inc.’s (AXGN) Biologics License Application for Avance Nerve Graft is under FDA review, with a decision due on December 5, 2025.The Avance Nerve Graft is a processed nerve allograft (human) intended for the surgical repair of peripheral nerve discontinuities to support regeneration across the defect.The function of peripheral nerves can be impacted by traumatic injuries or surgical procedures. Damage to these nerves, or failure to reconnect them properly, can lead to loss of muscle or organ function, loss of sensation, or the development of chronic pain.The company has been marketing Avance Nerve Graft as a human cells, tissues, and cellular/tissue-based product (HCT/P) in accordance with federal regulations since July 2007.If approved by the FDA, the Avance Nerve Graft would transition from HCT/P status to a fully licensed biologic.AXGN closed Wednesday’s (November 26, 2025) trading at $28.55, up 0.81%.