AxoGen Nerve Graft Decision Pushed Back by FDA
Regulator extends review for Avance Nerve Graft to December after new manufacturing data requires more time for evaluation.
AxoGen, Inc. (Nasdaq: AXGN) faces a longer wait for a key regulatory decision after the U.S. Food and Drug Administration extended its review timeline for the company's Avance Nerve Graft by three months.
The new Prescription Drug User Fee Act (PDUFA) goal date for the Biologics License Application (BLA) is now December 5, 2025, pushed back from the original target of September 5. The delay stems from an information submission by AxoGen that contained substantial new manufacturing and facility data.
The FDA deemed the submission a “Major Amendment” to the company's application, a designation that allows the agency additional time to conduct a thorough review of the new information. The regulator informed AxoGen of the extension on August 22, 2025, and indicated it now anticipates providing feedback on the product's labeling in November.
The approval would mark a critical milestone for AxoGen, transitioning its lead product from its current status as a human tissue product to a fully BLA-approved biologic. The Avance Nerve Graft is a processed human nerve allograft used for bridging severed peripheral nerves.
“We appreciate the FDA's thorough review and look forward to continuing our engagement with the agency to complete the transition of Avance Nerve Graft,” said Michael Dale, AxoGen’s Chief Executive Officer, in a statement addressing the delay.
AxoGen is a leader in developing technologies for peripheral nerve regeneration and repair. The delay in the BLA decision introduces a degree of uncertainty and pushes back a significant potential catalyst for the company, as investors watch for the final regulatory outcome later this year.