FDA Extends Axogen Avance Nerve Graft Review; Shares Drop 14%

The U.S. Food and Drug Administration has pushed back the Prescription Drug User Fee Act (PDUFA) goal date for Axogen Inc.’s Biologics License Application for Avance Nerve Graft by three months to Dec. 5, 2025. The agency classified recently submitted manufacturing and facility information as a Major Amendment, automatically adding time to the review clock. According to Axogen, the FDA now intends to provide feedback on product labeling in November, keeping the process within normal review procedures despite the extension. Chief Executive Officer Michael Dale said the company will continue working with regulators to complete the transition of Avance from a tissue product to a fully licensed biologic. Investors reacted negatively to the delay: Axogen shares fell roughly 13.9% in U.S. pre-market trading after climbing 76% over the past two months on optimism about the graft’s approval prospects.