FDA Extends PDUFA Goal Date for Axogen's Avance Nerve Graft to December 5, 2025.

Axogen, Inc. has announced that the FDA has extended the Prescription Drug User Fee Act goal date for its Biologics License Application for Avance Nerve Graft to December 5, 2025, due to a Major Amendment designation for new manufacturing and facility data. The FDA now anticipates providing feedback on product labeling in November 2025.

Axogen, Inc. (NASDAQ: AXGN) has 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 to December 5, 2025. This extension follows the FDA's designation of Axogen's recent submission, which included new manufacturing and facility data, as a Major Amendment to its BLA [1].

The FDA's decision to extend the PDUFA goal date allows for additional time to review the substantial new information submitted by Axogen in response to an FDA information request. This submission supports the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic. The FDA now anticipates providing feedback on product labeling in November 2025, consistent with PDUFA review procedures [2].

Axogen's Chief Executive Officer, Michael Dale, expressed appreciation for the FDA's thorough review and looks forward to continuing engagement with the agency to complete the transition. The extension provides Axogen with more time to address any potential regulatory concerns and finalize the approval process for Avance Nerve Graft.

Axogen, Inc. is the leading company focused on peripheral nerve regeneration and repair technologies. The company's product portfolio includes Avance Nerve Graft, a biologically active off-the-shelf processed human nerve allograft designed to bridge severed peripheral nerves without the comorbidities associated with a second surgical site [2].

References:
[1] https://www.stocktitan.net/news/AXGN/axogen-provides-update-on-fda-review-timeline-for-avance-nerve-tf0z5siv8c6t.html
[2] https://www.globenewswire.com/news-release/2025/08/25/3138317/0/en/Axogen-Provides-Update-on-FDA-Review-Timeline-for-Avance-Nerve-Graft.html