Axogen Provides Update on FDA Review Timeline for Avance Nerve Graft

Core Insights - The FDA has extended the PDUFA goal date for Axogen's Biologics License Application for Avance Nerve Graft by three months to December 5, 2025 [1][2] - The extension is due to a Major Amendment designation, which allows additional time for the FDA to review substantial new manufacturing and facility data submitted by the company [2] - Feedback on product labeling is anticipated from the FDA in November 2025, aligning with standard PDUFA review procedures [3] Company Overview - Axogen, Inc. specializes in the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [4] - The company aims to restore nerve function and improve the quality of life for patients with peripheral nerve injuries through innovative and clinically proven solutions [4] - Axogen's product portfolio includes several products designed for nerve repair, including Avance® Nerve Graft, Axoguard Nerve Connector®, and Axoguard Nerve Protector®, among others [4]