FDA Pushes Back Axogen Avance Nerve Graft Decision By 3 Months

The U.S. Food and Drug Administration (FDA) on Monday extended the Prescription Drug User Fee Act (PDUFA) goal date for Axogen Inc.’s (NASDAQ:AXGN) Biologics License Application (BLA) for Avance Nerve Graft by three months to December 5.

Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site.

On August 22, Axogen 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. 

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Under FDA guidelines, this designation allows 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 anticipates providing feedback on product labeling in November 2025, consistent with PDUFA review procedures.

“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 from a tissue product to a BLA-approved biologic,” said Michael Dale, Axogen’s Chief Executive Officer.

In its second-quarter earnings release, Axogen raised revenue guidance to at least 17% growth, or $219 million for fiscal 2025.

The company expects a gross margin of 73%-75%, reflecting one-time costs, mainly related to an anticipated Avance Nerve Graft BLA approval, which is expected to negatively impact gross margin by approximately 1%. The company reiterated that it expected the net cash flow to be positive for the full year.

Price Action: AXGN stock is trading lower by 8.86% to $14.82 at last check Monday.

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