FDA Delays Axogen Avance Nerve Graft Decision; Stock Drops 14%

Axogen Inc. said the U.S. Food and Drug Administration has classified recent manufacturing and facility data submitted for its Avance Nerve Graft as a major amendment, pushing back the Prescription Drug User Fee Act goal date by three months to Dec. 5, 2025. The agency now expects to give labeling feedback in November. The extension lengthens the review of Axogen’s biologics license application as the company seeks to transition Avance from a tissue product to a fully approved biologic. Chief Executive Officer Michael Dale said the company will continue working with regulators to complete the review. Investors reacted sharply: Axogen shares fell about 14% in pre-market trading after having gained roughly 76% over the past two months, as the delay defers potential approval and commercialization plans.