Axogen completes BLA submission to FDA for Avance Nerve Graft; priority review requested

Axogen, Inc.

FDA submission for Avance Nerve Graft completed under rolling review process on Sept. 6, 2024.
Company requested priority review; if granted, review timeline could be 6 months vs. standard 10 months.
Avance previously received RMAT designation from FDA under 21st Century Cures Act.
FDA expected to notify acceptance and confirm review timeline within approximately 60 days.
Company on track for FDA approvability determination between April and September 2025.

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