AxoGen: FDA extends PDUFA date for BLA for Avance Nerve Graft to December 5

Axogen (AXGN) announced that the U.S. FDA has extended the Prescription Drug User Fee Act goal date for its Biologics License Application for Avance Nerve Graft by three months to December 5, 2025. On August 22, 2025, the company received a communication from the FDA indicating that the information submitted by the company in response to an FDA information request, which included substantial new manufacturing and facility data not previously reviewed by the Agency, was deemed a Major Amendment to its BLA. Under FDA guidelines, this designation allows for additional time to review the submission. As a result, the FDA has extended the PDUFA goal date to December 5, 2025. The FDA also informed the company that it now anticipates providing feedback on product labeling in November 2025, consistent with PDUFA review procedures.