Axogen, Inc. provides an update on the FDA review timeline for Avance Nerve Graft, with the FDA extending the Prescription Drug User Fee Act (PDUFA) goal date by three months to December 5, 2025.
The extension was due to a Major Amendment to the Biologics License Application (BLA) which included substantial new manufacturing and facility data.
The FDA anticipates providing feedback on product labeling in November 2025, in line with PDUFA review procedures.
FDA Extension
FDA extended the PDUFA goal date for Axogen's Avance Nerve Graft to December 5, 2025, allowing more time for review due to a Major Amendment.
Product Labeling Feedback
The FDA will provide feedback on product labeling in November 2025, aligning with PDUFA review procedures.
Company Statement
Axogen's CEO appreciates the thorough FDA review and looks forward to completing the transition of Avance Nerve Graft to a BLA-approved biologic.
- The extension provides Axogen more time for the FDA review process, potentially ensuring a more comprehensive evaluation of the submitted data and enhancing the approval prospects for Avance Nerve Graft.
- Delay in the PDUFA goal date might have short-term market implications on Axogen's stock price and stakeholder sentiment, influencing investor strategies and market perceptions.
Axogen's Avance Nerve Graft continues to undergo FDA review with an extended timeline. The company remains focused on regulatory compliance and advancing towards the biologic approval for this innovative surgical solution.