Axogen, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for Avance Nerve Graft by three months. The new target decision date is December 5, 2025.
The extension was a result of information submitted by Axogen in response to an FDA information request, which included substantial new manufacturing and facility data. This submission was deemed a Major Amendment to its BLA by the FDA, necessitating additional time for review.
The FDA also informed Axogen that it now anticipates providing feedback on product labeling in November 2025, consistent with standard PDUFA review procedures. This delay pushes back the anticipated regulatory approval for Avance Nerve Graft, a key catalyst for the company.
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