Axogen Shares Plummet on FDA's Extended Review of Avance Nerve Graft

Axogen shares fell 15% in premarket trading after the FDA extended its review of the Avance nerve graft by three months. The FDA deemed additional information filed at their request as a major amendment, requiring more time for review. The target action date is now Dec. 5, with feedback on product labeling expected in November.

Axogen Inc. (NASDAQ: AXGN) experienced a 15% decline in premarket trading on July 2, 2025, following the U.S. Food and Drug Administration's (FDA) extension of the review of its Biologics License Application (BLA) for Avance Nerve Graft. The FDA has pushed the Prescription Drug User Fee Act (PDUFA) goal date back by three months to December 5, 2025, citing substantial new manufacturing and facility data submitted by Axogen as a Major Amendment to the BLA [1].

The extension allows the FDA additional time to review the new information, which supports the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic. The FDA anticipates providing feedback on product labeling in November 2025, aligning with PDUFA review procedures [1].

Michael Dale, Axogen's Chief Executive Officer, expressed appreciation for the FDA's thorough review, stating, "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" [1].

Axogen specializes in technologies for peripheral nerve regeneration and repair, with products designed to assist in the treatment of peripheral nerve injuries. The company's product portfolio includes Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard HA+ Nerve Protector, Axoguard Nerve Cap, and Avive+ Soft Tissue Matrix, available in multiple countries [1].

The extension of the PDUFA goal date by three months signals potential delays in product approval, which may negatively impact Axogen's market position and financial performance. The FDA's designation of the submitted information as a Major Amendment indicates significant concerns about manufacturing or data compliance, which could reflect poorly on the company's operational capabilities [2].

Investors should closely monitor the regulatory process and the company's response to any potential requests for additional data or information. The need for additional time for FDA review and labeling feedback may lead to uncertainties regarding the company's future prospects and timeline for product commercialization.

References:
[1] https://www.stocktitan.net/news/AXGN/axogen-provides-update-on-fda-review-timeline-for-avance-nerve-tf0z5siv8c6t.html
[2] https://www.quiverquant.com/news/Axogen%2C+Inc.+Receives+FDA+Extension+for+Avance%C2%AE+Nerve+Graft+Biologics+License+Application+Review